EUROPEANPHARMACOPOEIA8.0 INDEX - EDQM · EUROPEANPHARMACOPOEIA8.0 3604 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 8.0

INDEXEnglish index ...................................................................... 3605 Latin index ............................................................................... 3639

General Notices (1) apply to all monographs and other texts 3603


3604 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 8.0 Index

Numerics1. General notices ......................................................................... 32.1.1. Droppers ........................................................................... 152.1.2. Comparative table of porosity of sintered-glass filters.. 152.1.3. Ultraviolet ray lamps for analytical purposes............... 152.1.4. Sieves ................................................................................. 162.1.5. Tubes for comparative tests ............................................ 172.1.6. Gas detector tubes............................................................ 172.1. Apparatus ............................................................................. 152.2.10. Viscosity - Rotating viscometer method ..................... 282.2.11. Distillation range ........................................................... 302.2.12. Boiling point................................................................... 312.2.13. Determination of water by distillation ........................ 312.2.14. Melting point - capillary method................................. 322.2.15. Melting point - open capillary method ....................... 322.2.16. Melting point - instantaneous method........................ 322.2.17. Drop point ...................................................................... 322.2.18. Freezing point................................................................. 342.2.19. Amperometric titration................................................. 342.2.1. Clarity and degree of opalescence of liquids ................ 212.2.20. Potentiometric titration ................................................ 342.2.21. Fluorimetry..................................................................... 352.2.22. Atomic emission spectrometry .................................... 352.2.23. Atomic absorption spectrometry ................................. 362.2.24. Absorption spectrophotometry, infrared.................... 382.2.25. Absorption spectrophotometry, ultraviolet andvisible ......................................................................................... 40

2.2.26. Paper chromatography .................................................. 422.2.27. Thin-layer chromatography.......................................... 422.2.28. Gas chromatography...................................................... 432.2.29. Liquid chromatography................................................. 452.2.2. Degree of coloration of liquids....................................... 222.2.30. Size-exclusion chromatography ................................... 462.2.31. Electrophoresis ............................................................... 472.2.31. Electrophoresis (5.8.)................................................... 6772.2.32. Loss on drying................................................................ 522.2.33. Nuclear magnetic resonance spectrometry ................ 522.2.34. Thermal analysis ............................................................ 552.2.35. Osmolality....................................................................... 572.2.36. Potentiometric determination of ionicconcentration using ion-selective electrodes ........................ 58

2.2.37. X-ray fluorescence spectrometry ................................. 592.2.38. Conductivity ................................................................... 592.2.39. Molecular mass distribution in dextrans .................... 602.2.3. Potentiometric determination of pH............................. 242.2.40. Near-infrared spectroscopy .......................................... 622.2.41. Circular dichroism......................................................... 672.2.42. Density of solids............................................................. 682.2.43. Mass spectrometry......................................................... 692.2.44. Total organic carbon in water for pharmaceuticaluse............................................................................................... 71

2.2.45. Supercritical fluid chromatography ............................. 722.2.46. Chromatographic separation techniques .................... 722.2.47. Capillary electrophoresis............................................... 792.2.47. Capillary electrophoresis (5.8.) .................................. 6772.2.48. Raman spectrometry ..................................................... 842.2.49. Falling ball viscometer method.................................... 852.2.4. Relationship between reaction of solution,approximate pH and colour of certain indicators ................ 25

2.2.54. Isoelectric focusing ........................................................ 852.2.54. Isoelectric focusing (5.8.) ............................................ 6772.2.55. Peptide mapping ............................................................ 872.2.55. Peptide mapping (5.8.) ................................................ 6772.2.56. Amino acid analysis....................................................... 902.2.56. Amino acid analysis (5.8.)........................................... 6772.2.57. Inductively coupled plasma-atomic emissionspectrometry ............................................................................. 97

2.2.58. Inductively coupled plasma-mass spectrometry........ 982.2.59. Glycan analysis of glycoproteins ................................ 1002.2.5. Relative density................................................................. 252.2.60. Melting point - instrumental method ....................... 105

2.2.61. Characterisation of crystalline solids bymicrocalorimetry and solution calorimetry........................ 106

2.2.64. Peptide identification by nuclear magnetic resonancespectrometry ........................................................................... 109

2.2.65. Voltametric titration .................................................... 1092.2.66. Detection and measurement of radioactivity ........... 1102.2.6. Refractive index................................................................ 262.2.7. Optical rotation ................................................................ 262.2.8. Viscosity ............................................................................ 272.2.9. Capillary viscometer method ......................................... 272.2. Physical and physicochemical methods ........................... 212.3.1. Identification reactions of ions and functionalgroups ...................................................................................... 119

2.3.2. Identification of fatty oils by thin-layerchromatography...................................................................... 122

2.3.3. Identification of phenothiazines by thin-layerchromatography...................................................................... 123

2.3.4. Odour .............................................................................. 1232.3. Identification...................................................................... 1192.4.10. Lead in sugars............................................................... 1312.4.11. Phosphates .................................................................... 1312.4.12. Potassium...................................................................... 1322.4.13. Sulfates........................................................................... 1322.4.14. Sulfated ash ................................................................... 1322.4.14. Sulfated ash (5.8.)......................................................... 6782.4.15. Nickel in polyols........................................................... 1322.4.16. Total ash ........................................................................ 1322.4.17. Aluminium ................................................................... 1322.4.18. Free formaldehyde ....................................................... 1322.4.19. Alkaline impurities in fatty oils.................................. 1332.4.1. Ammonium .................................................................... 1272.4.20. Determination of metal catalyst or metal reagentresidues .................................................................................... 133

2.4.21. Foreign oils in fatty oils by thin-layerchromatography...................................................................... 136

2.4.22. Composition of fatty acids by gas chromatography.. 1362.4.23. Sterols in fatty oils........................................................ 1392.4.24. Identification and control of residual solvents ......... 1412.4.25. Ethylene oxide and dioxan.......................................... 1452.4.26. N,N-Dimethylaniline ................................................... 1462.4.27. Heavy metals in herbal drugs and fatty oils ............. 1472.4.28. 2-Ethylhexanoic acid ................................................... 1482.4.29. Composition of fatty acids in oils rich in omega-3acids.......................................................................................... 148

2.4.2. Arsenic............................................................................. 1272.4.30. Ethylene glycol and diethylene glycol in ethoxylatedsubstances ................................................................................ 150

2.4.31. Nickel in hydrogenated vegetable oils ....................... 1502.4.32. Total cholesterol in oils rich in omega-3 acids ......... 1512.4.3. Calcium ........................................................................... 1272.4.4. Chlorides ......................................................................... 1272.4.5. Fluorides.......................................................................... 1282.4.6. Magnesium ..................................................................... 1282.4.7. Magnesium and alkaline-earth metals ........................ 1282.4.8. Heavy metals................................................................... 1282.4.9. Iron .................................................................................. 1312.4. Limit tests........................................................................... 1272.5.10. Oxygen-flask method .................................................. 1582.5.11. Complexometric titrations.......................................... 1582.5.12. Water : semi-micro determination ............................. 1582.5.13. Aluminium in adsorbed vaccines .............................. 1592.5.14. Calcium in adsorbed vaccines .................................... 1592.5.15. Phenol in immunosera and vaccines......................... 1592.5.16. Protein in polysaccharide vaccines ............................ 1592.5.17. Nucleic acids in polysaccharide vaccines .................. 1602.5.18. Phosphorus in polysaccharide vaccines .................... 1602.5.19. O-Acetyl in polysaccharide vaccines ......................... 1602.5.1. Acid value........................................................................ 1552.5.20. Hexosamines in polysaccharide vaccines.................. 1602.5.21. Methylpentoses in polysaccharide vaccines.............. 1612.5.22. Uronic acids in polysaccharide vaccines ................... 1612.5.23. Sialic acid in polysaccharide vaccines ....................... 1612.5.24. Carbon dioxide in gases .............................................. 161


Index EUROPEAN PHARMACOPOEIA 8.0

2.5.25. Carbon monoxide in gases ......................................... 1622.5.26. Nitrogen monoxide and nitrogen dioxide in gases.. 1632.5.27. Oxygen in gases............................................................ 1632.5.28. Water in gases............................................................... 1632.5.29. Sulfur dioxide ............................................................... 1642.5.2. Ester value....................................................................... 1552.5.30. Oxidising substances ................................................... 1642.5.31. Ribose in polysaccharide vaccines ............................. 1642.5.32. Water : micro determination....................................... 1642.5.33. Total protein ................................................................. 1652.5.34. Acetic acid in synthetic peptides................................ 1682.5.35. Nitrous oxide in gases ................................................. 1682.5.36. Anisidine value............................................................. 1692.5.37. Methyl, ethyl and isopropyl methanesulfonate inmethanesulfonic acid ............................................................. 169

2.5.38. Methyl, ethyl and isopropyl methanesulfonate in activesubstances ................................................................................ 170

2.5.39. Methanesulfonyl chloride in methanesulfonicacid ........................................................................................... 171

2.5.3. Hydroxyl value ............................................................... 1552.5.4. Iodine value .................................................................... 1552.5.5. Peroxide value................................................................. 1562.5.6. Saponification value....................................................... 1572.5.7. Unsaponifiable matter ................................................... 1572.5.8. Determination of primary aromatic amino-nitrogen.................................................................................... 157

2.5.9. Determination of nitrogen by sulfuric aciddigestion .................................................................................. 157

2.5. Assays ................................................................................. 1552.6.10. Histamine...................................................................... 1842.6.11. Depressor substances................................................... 1852.6.12. Microbiological examination of non-sterile products :microbial enumeration tests.................................................. 185

2.6.12. Microbiological examination of non-sterile products :microbial enumeration tests (5.8.) ....................................... 678

2.6.13. Microbiological examination of non-sterile products :test for specified micro-organisms ....................................... 189

2.6.13. Microbiological examination of non-sterile products :test for specified micro-organisms (5.8.) ............................. 678

2.6.14. Bacterial endotoxins .................................................... 1942.6.15. Prekallikrein activator ................................................. 1982.6.16. Tests for extraneous agents in viral vaccines for humanuse ............................................................................................ 198

2.6.17. Test for anticomplementary activity ofimmunoglobulin..................................................................... 200

2.6.18. Test for neurovirulence of live virus vaccines .......... 2022.6.19. Test for neurovirulence of poliomyelitis vaccine(oral)......................................................................................... 202

2.6.1. Sterility ............................................................................ 1752.6.1. Sterility (5.8.) .................................................................. 6782.6.20. Anti-A and anti-B haemagglutinins .......................... 2032.6.21. Nucleic acid amplification techniques....................... 2042.6.22. Activated coagulation factors ..................................... 2092.6.24. Avian viral vaccines : tests for extraneous agents inseed lots ................................................................................... 209

2.6.25. Avian live virus vaccines : tests for extraneous agents inbatches of finished product ................................................... 212

2.6.26. Test for anti-D antibodies in human immunoglobu-lin.............................................................................................. 215

2.6.27. Microbiological control of cellular products ............ 2162.6.2. Mycobacteria .................................................................. 1782.6.30. Monocyte-activation test............................................. 2172.6.31. Microbiological examination of herbal medicinalproducts for oral use and extracts used in theirpreparation .............................................................................. 222

2.6.33. Residual pertussis toxin and irreversibility of pertussistoxoid ....................................................................................... 224

2.6.7. Mycoplasmas .................................................................. 1782.6.8. Pyrogens.......................................................................... 1832.6.9. Abnormal toxicity .......................................................... 1842.6. Biological tests ................................................................... 1752.7.10. Assay of human coagulation factor VII .................... 2472.7.11. Assay of human coagulation factor IX ...................... 248

2.7.12. Assay of heparin in coagulation factors .................... 2492.7.13. Assay of human anti-D immunoglobulin ................. 2492.7.14. Assay of hepatitis A vaccine ....................................... 2512.7.15. Assay of hepatitis B vaccine (rDNA) ......................... 2522.7.16. Assay of pertussis vaccine (acellular) ........................ 2522.7.17. Assay of human antithrombin III .............................. 2542.7.18. Assay of human coagulation factor II ....................... 2542.7.19. Assay of human coagulation factor X........................ 2552.7.19. Assay of human coagulation factor X (2.7.19.) ........ 2552.7.1. Immunochemical methods........................................... 2292.7.20. In vivo assay of poliomyelitis vaccine (inactivated).. 2552.7.21. Assay of human von Willebrand factor..................... 2572.7.22. Assay of human coagulation factor XI ...................... 2582.7.23. Numeration of CD34/CD45+ cells inhaematopoietic products ....................................................... 258

2.7.24. Flow cytometry ............................................................ 2592.7.25. Assay of human plasmin inhibitor............................. 2612.7.27. Flocculation value (Lf) of diphtheria and tetanus toxinsand toxoids (Ramon assay) ................................................... 261

2.7.28. Colony-forming cell assay for humanhaematopoietic progenitor cells............................................ 262

2.7.29. Nucleated cell count and viability.............................. 2632.7.2. Microbiological assay of antibiotics............................. 2302.7.30. Assay of human protein C .......................................... 2652.7.31. Assay of human protein S ........................................... 2662.7.32. Assay of human α-1-proteinase inhibitor ................. 2662.7.4. Assay of human coagulation factor VIII ..................... 2362.7.5. Assay of heparin............................................................. 2372.7.6. Assay of diphtheria vaccine (adsorbed) ...................... 2372.7.7. Assay of pertussis vaccine (whole cell)........................ 2422.7.8. Assay of tetanus vaccine (adsorbed)............................ 2422.7.9. Test for Fc function of immunoglobulin..................... 2462.7. Biological assays ................................................................ 2292.8.10. Solubility in alcohol of essential oils.......................... 2722.8.11. Assay of 1,8-cineole in essential oils.......................... 2722.8.12. Essential oils in herbal drugs...................................... 2732.8.13. Pesticide residues ......................................................... 2742.8.14. Tannins in herbal drugs .............................................. 2752.8.15. Bitterness value............................................................. 2762.8.16. Dry residue of extracts ................................................ 2762.8.17. Loss on drying of extracts........................................... 2762.8.18. Determination of aflatoxin B1 in herbal drugs ......... 2762.8.1. Ash insoluble in hydrochloric acid .............................. 2712.8.20. Herbal drugs : sampling and sample preparation .... 2782.8.21. Test for aristolochic acids in herbal drugs ................ 2792.8.22. Determination of ochratoxin A in herbal drugs ...... 2812.8.23. Microscopic examination of herbal drugs ................ 2822.8.2. Foreign matter ................................................................ 2712.8.3. Stomata and stomatal index.......................................... 2712.8.4. Swelling index................................................................. 2712.8.5. Water in essential oils .................................................... 2712.8.6. Foreign esters in essential oils ...................................... 2712.8.7. Fatty oils and resinified essential oils in essentialoils ............................................................................................ 271

2.8.8. Odour and taste of essential oils .................................. 2722.8.9. Residue on evaporation of essential oils ..................... 2722.8. Methods in pharmacognosy ............................................ 2712.9.10. Ethanol content ............................................................ 3012.9.11. Test for methanol and 2-propanol ............................. 3042.9.12. Sieve test........................................................................ 3052.9.14. Specific surface area by air permeability................... 3052.9.16. Flowability..................................................................... 3072.9.17. Test for extractable volume of parenteralpreparations ............................................................................ 308

2.9.17. Test for extractable volume of parenteral preparations(5.8.) ......................................................................................... 679

2.9.18. Preparations for inhalation : aerodynamic assessmentof fine particles........................................................................ 309

2.9.19. Particulate contamination : sub-visible particles...... 3212.9.19. Particulate contamination : sub-visible particles(5.8.) ......................................................................................... 679

2.9.1. Disintegration of tablets and capsules ......................... 2852.9.1. Disintegration of tablets and capsules (5.8.)............... 678



2.9.20. Particulate contamination : visible particles ............. 3232.9.22. Softening time determination of lipophilicsuppositories ........................................................................... 323

2.9.23. Gas pycnometric density of solids ............................. 3242.9.25. Dissolution test for medicated chewing gums ......... 3252.9.26. Specific surface area by gas adsorption ..................... 3292.9.26. Specific surface area by gas adsorption (5.8.) ........... 6792.9.27. Uniformity of mass of delivered doses from multidosecontainers ................................................................................ 331

2.9.29. Intrinsic dissolution..................................................... 3312.9.2. Disintegration of suppositories and pessaries ............ 2872.9.31. Particle size analysis by laser light diffraction.......... 3332.9.32. Porosity and pore-size distribution of solids bymercury porosimetry ............................................................. 336

2.9.33. Characterisation of crystalline and partially crystallinesolids by X-ray powder diffraction (XRPD) ....................... 339

2.9.34. Bulk density and tapped density of powders............ 3432.9.35. Powder fineness............................................................ 3462.9.36. Powder flow .................................................................. 3462.9.36. Powder flow (5.8.) ........................................................ 6792.9.37. Optical microscopy...................................................... 3492.9.37. Optical microscopy (5.8.)............................................ 6792.9.38. Particle-size distribution estimation by analyticalsieving ...................................................................................... 351

2.9.38. Particle-size distribution estimation by analyticalsieving (5.8.) ............................................................................ 679

2.9.39. Water-solid interactions : determination ofsorption-desorption isotherms and of water activity......... 353

2.9.3. Dissolution test for solid dosage forms ....................... 2882.9.40. Uniformity of dosage units ......................................... 3572.9.41. Friability of granules and spheroids .......................... 3592.9.42. Dissolution test for lipophilic solid dosage forms ... 3612.9.43. Apparent dissolution ................................................... 3612.9.44. Preparations for nebulisation : characterisation....... 3632.9.45. Wettability of porous solids including powders....... 3652.9.47. Demonstration of uniformity of dosage units usinglarge sample sizes.................................................................... 368

2.9.4. Dissolution test for transdermal patches .................... 2952.9.5. Uniformity of mass of single-dose preparations ........ 2972.9.6. Uniformity of content of single-dose preparations.... 2982.9.7. Friability of uncoated tablets ........................................ 2982.9.7. Friability of uncoated tablets (5.8.) .............................. 6782.9.8. Resistance to crushing of tablets .................................. 2992.9.9. Measurement of consistency by penetrometry .......... 2992.9. Pharmaceutical technical procedures ............................. 2853.1.10. Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions......... 395

3.1.11. Materials based on non-plasticised poly(vinylchloride) for containers for dry dosage forms for oraladministration......................................................................... 397

3.1.1.1. Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components......... 375

3.1.1.2. Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents ............................................................................. 378

3.1.13. Plastic additives ............................................................ 3983.1.14. Materials based on plasticised poly(vinyl chloride)for containers for aqueous solutions for intravenousinfusion .................................................................................... 401

3.1.15. Polyethylene terephthalate for containers forpreparations not for parenteral use ...................................... 403

3.1.1. Materials for containers for human blood and bloodcomponents ............................................................................. 375

3.1.3. Polyolefins ....................................................................... 3803.1.4. Polyethylene without additives for containers forparenteral preparations and for ophthalmic preparations.. 383

3.1.5. Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations ................... 384

3.1.6. Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations ......................... 388

3.1.7. Poly(ethylene - vinyl acetate) for containers and tubingfor total parenteral nutrition preparations .......................... 391

3.1.8. Silicone oil used as a lubricant ..................................... 393

3.1.9. Silicone elastomer for closures and tubing ................. 3943.1. Materials used for the manufacture of containers ........ 3753.2.1. Glass containers for pharmaceutical use..................... 4093.2.2.1. Plastic containers for aqueous solutions forinfusion .................................................................................... 414

3.2.2. Plastic containers and closures for pharmaceuticaluse............................................................................................. 414

3.2.3. Sterile plastic containers for human blood andblood components .................................................................. 415

3.2.4. Empty sterile containers of plasticised poly(vinylchloride) for human blood and blood components........... 417

3.2.5. Sterile containers of plasticised poly(vinyl chloride) forhuman blood containing anticoagulant solution ............... 418

3.2.6. Sets for the transfusion of blood and bloodcomponents ............................................................................. 418

3.2.8. Sterile single-use plastic syringes ................................. 4193.2.9. Rubber closures for containers for aqueousparenteral preparations, for powders and forfreeze-dried powders.............................................................. 421

3.2. Containers.......................................................................... 4093-O-Desacyl-4′-monophosphoryl lipid A............................ 20004.1.1. Reagents .......................................................................... 4254.1.2. Standard solutions for limit tests ................................. 5364.1.3. Buffer solutions .............................................................. 5404.1. Reagents, standard solutions, buffer solutions .............. 4254.2.1. Primary standards for volumetric solutions ............... 5454.2.2. Volumetric solutions...................................................... 5464.2. Volumetric analysis........................................................... 5454-Aminobenzoic acid ............................................................. 15394. Reagents................................................................................. 4255.10. Control of impurities in substances for pharmaceuticaluse............................................................................................. 689

5.1.10. Guidelines for using the test for bacterialendotoxins ............................................................................... 572

5.11. Characters section in monographs ............................... 6955.1.1. Methods of preparation of sterile products ................ 5555.1.2. Biological indicators of sterilisation ............................ 5565.12. Reference standards ........................................................ 6995.1.3. Efficacy of antimicrobial preservation ........................ 5575.14. Gene transfer medicinal products for human use ...... 7055.1.4. Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use......... 559

5.1.4. Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use(5.8.) ......................................................................................... 679

5.1.5. Application of the F0 concept to steam sterilisation ofaqueous preparations ............................................................. 560

5.15. Functionality-related characteristics of excipients...... 7195.1.6. Alternative methods for control of microbiologicalquality ...................................................................................... 560

5.16. Crystallinity ..................................................................... 7235.17.1. Recommendations on dissolution testing................. 7275.17. Recommendations on methods for dosage formstesting....................................................................................... 727

5.1.7. Viral safety ...................................................................... 5715.1.8. Microbiological quality of herbal medicinal products fororal use and extracts used in their preparation .................. 571

5.1.9. Guidelines for using the test for sterility..................... 5725.1. General texts on microbiology ........................................ 5555.20. Metal catalyst or metal reagent residues ...................... 7335.2.1. Terminology used in monographs on biologicalproducts ................................................................................... 579

5.2.2. Chicken flocks free from specified pathogens for theproduction and quality control of vaccines......................... 579

5.2.3. Cell substrates for the production of vaccines for humanuse............................................................................................. 582

5.2.4. Cell cultures for the production of veterinaryvaccines .................................................................................... 585

5.2.5. Substances of animal origin for the production ofimmunological veterinary medicinal products .................. 587

5.2.6. Evaluation of safety of veterinary vaccines andimmunosera ........................................................................... 588



5.2.7. Evaluation of efficacy of veterinary vaccines andimmunosera ............................................................................ 591

5.2.8. Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts ................................................................................... 592

5.2.9. Evaluation of safety of each batch of immunosera forveterinary use.......................................................................... 604

5.2. General texts on biological products .............................. 5795.3. Statistical analysis of results of biological assays andtests........................................................................................... 607

5.4. Residual solvents ............................................................... 6395.5. Alcoholimetric tables........................................................ 6495.6. Assay of interferons .......................................................... 6635.7. Table of physical characteristics of radionuclidesmentioned in the European Pharmacopoeia ...................... 667

5.8. Pharmacopoeial harmonisation ...................................... 6775.9. Polymorphism ................................................................... 685

AAbacavir sulfate....................................................................... 1459Abbreviations and symbols (1.) .................................................. 3Abnormal toxicity (2.6.9.)........................................................ 184Absorption spectrophotometry, infrared (2.2.24.) ................. 38Absorption spectrophotometry, ultraviolet and visible(2.2.25.) ...................................................................................... 40

Acacia ....................................................................................... 1135Acacia, spray-dried ................................................................. 1460Acamprosate calcium ............................................................. 1461Acanthopanax bark ................................................................ 1136Acarbose .................................................................................. 1462Acebutolol hydrochloride ...................................................... 1464Aceclofenac.............................................................................. 1466Acemetacin .............................................................................. 1467Acesulfame potassium............................................................ 1469Acetate trihydrate, sodium .................................................... 3224Acetazolamide......................................................................... 1470Acetic acid, glacial .................................................................. 1471Acetic acid in synthetic peptides (2.5.34.) ............................. 168Acetone .................................................................................... 1472Acetylcholine chloride ........................................................... 1473Acetylcysteine.......................................................................... 1473β-Acetyldigoxin....................................................................... 1475Acetylsalicylic acid ................................................................. 1477Acetyltryptophan, N- ............................................................. 1479Acetyltyrosine, N- ................................................................... 1481Aciclovir................................................................................... 1482Acid value (2.5.1.) ..................................................................... 155Acitretin ................................................................................... 1484Actinobacillosis vaccine (inactivated), porcine .................. 1000Activated charcoal .................................................................. 1839Activated coagulation factors (2.6.22.)................................... 209Adapalene ................................................................................ 1485Additives, plastic (3.1.13.) ....................................................... 398Adenine.................................................................................... 1487Adeno-associated-virus vectors for human use .................... 714Adenosine ................................................................................ 1487Adenovirus vaccine (inactivated), canine.............................. 945Adenovirus vaccine (live), canine........................................... 946Adipic acid............................................................................... 1489Adrenaline ............................................................................... 1490Adrenaline tartrate ................................................................. 1491Adsorption, gas, specific surface area by (2.9.26.)................ 329Adsorption, gas, specific surface area by (2.9.26.) (5.8.) ..... 679Aerodynamic assessment of fine particles in preparations forinhalation (2.9.18.) ................................................................. 309

Aflatoxin B1 in herbal drugs, determination of (2.8.18.) ..... 276Agar .......................................................................................... 1136Agnus castus fruit ................................................................... 1137Agrimony................................................................................. 1138Air, medicinal ......................................................................... 1492Air, synthetic medicinal......................................................... 1494Alanine..................................................................................... 1495

Albendazole............................................................................. 1496Albumin solution, human ..................................................... 2404Alchemilla................................................................................ 1139Alcoholimetric tables (5.5.) ..................................................... 649Alcuronium chloride.............................................................. 1497Alendronate, sodium.............................................................. 3225Alexandrian senna pods ........................................................ 1384Alfacalcidol.............................................................................. 1498Alfadex ..................................................................................... 1499Alfentanil hydrochloride ....................................................... 1501Alfuzosin hydrochloride ........................................................ 1502Alginate, sodium..................................................................... 3226Alginic acid.............................................................................. 1503Alimemazine hemitartrate..................................................... 1504Alkaline-earth metals and magnesium (2.4.7.)..................... 128Alkaline impurities in fatty oils (2.4.19.) ............................... 133Allantoin .................................................................................. 1505Allergen products ..................................................................... 741Allopurinol .............................................................................. 1505all-rac-α-Tocopherol............................................................... 3436all-rac-α-Tocopheryl acetate.................................................. 3438Almagate .................................................................................. 1507Almond oil, refined ................................................................ 1508Almond oil, virgin .................................................................. 1509Aloes, Barbados ...................................................................... 1140Aloes, Cape.............................................................................. 1141Aloes dry extract, standardised............................................. 1142Alovudine (18F) injection ....................................................... 1045Alphacyclodextrin .................................................................. 1499Alprazolam .............................................................................. 1509Alprenolol hydrochloride ...................................................... 1511Alprostadil ............................................................................... 1512Alteplase for injection ............................................................ 1515Alternative methods for control of microbiological quality(5.1.6.) ...................................................................................... 560

Altizide..................................................................................... 1518Alum......................................................................................... 1519Aluminium (2.4.17.)................................................................. 132Aluminium chloride hexahydrate......................................... 1519Aluminium hydroxide, hydrated, for adsorption ............... 1520Aluminium in adsorbed vaccines (2.5.13.)............................ 159Aluminium magnesium silicate ............................................ 1521Aluminium oxide, hydrated .................................................. 1522Aluminium phosphate gel ..................................................... 1522Aluminium phosphate, hydrated.......................................... 1523Aluminium sodium silicate ................................................... 1524Aluminium stearate................................................................ 1525Aluminium sulfate.................................................................. 1527Alverine citrate........................................................................ 1527Amantadine hydrochloride ................................................... 1528Ambroxol hydrochloride ....................................................... 1529Amfetamine sulfate ................................................................ 1531Amidotrizoate, sodium .......................................................... 3227Amidotrizoic acid dihydrate ................................................. 1531Amikacin ................................................................................. 1533Amikacin sulfate ..................................................................... 1535Amiloride hydrochloride ....................................................... 1538Amino acid analysis (2.2.56.) .................................................... 90Amino acid analysis (2.2.56.) (5.8.)........................................ 677Aminobenzoic acid, 4- ........................................................... 1539Aminocaproic acid ................................................................. 1540Aminoglutethimide ................................................................ 1541Aminophylline, anhydrous.................................................... 3398Aminophylline hydrate .......................................................... 3399Aminosalicylate dihydrate, sodium...................................... 3228Amiodarone hydrochloride................................................... 1542Amisulpride............................................................................. 1544Amitriptyline hydrochloride ................................................. 1546Amlodipine besilate................................................................ 1547Ammonia (13N) injection....................................................... 1047Ammonia solution, concentrated ......................................... 1548Ammonio methacrylate copolymer (type A)...................... 1549Ammonio methacrylate copolymer (type B) ...................... 1550



Ammonium (2.4.1.).................................................................. 127Ammonium bromide ............................................................. 1551Ammonium chloride.............................................................. 1552Ammonium glycyrrhizate ..................................................... 1552Ammonium hydrogen carbonate ......................................... 1553Amobarbital ............................................................................ 1554Amobarbital sodium .............................................................. 1554Amoxicillin sodium................................................................ 1555Amoxicillin trihydrate............................................................ 1557Amperometric titration (2.2.19.) .............................................. 34Amphotericin B ...................................................................... 1560Ampicillin, anhydrous .......................................................... 1561Ampicillin sodium.................................................................. 1564Ampicillin trihydrate.............................................................. 1566Amylmetacresol ...................................................................... 1568Anaemia vaccine (live), chicken, infectious .......................... 984Anaesthetic ether .................................................................... 2185Analysis, thermal (2.2.34.)......................................................... 55Analytical sieving, particle-size distribution estimation by(2.9.38.) .................................................................................... 351

Analytical sieving, particle-size distribution estimation by(2.9.38.) (5.8.).......................................................................... 679

Anamirta cocculus for homoeopathic preparations .......... 1442Anastrozole.............................................................................. 1570Angelica archangelica root .................................................... 1142Angelica dahurica root........................................................... 1143Angelica pubescens root ........................................................ 1145Angelica sinensis root ............................................................ 1147Animal anti-T lymphocyte immunoglobulin for humanuse........................................................................................... 1575

Animal immunosera for human use ...................................... 748Animal spongiform encephalopathies, products with risk oftransmitting agents of ............................................................ 759

Animal spongiform encephalopathy agents, minimising therisk of transmitting via human and veterinary medicinalproducts (5.2.8.)...................................................................... 592

Aniseed .................................................................................... 1150Anise oil ................................................................................... 1148Anisidine value (2.5.36.) .......................................................... 169Antazoline hydrochloride...................................................... 1571Anthrax spore vaccine (live) for veterinary use.................... 921Anthrax vaccine for human use (adsorbed, prepared fromculture filtrates)....................................................................... 817

Anti-A and anti-B haemagglutinins (2.6.20.)........................ 203Antibiotics, microbiological assay of (2.7.2.) ........................ 230Antibodies (anti-D) in human immunoglobulin, test for(2.6.26.) .................................................................................... 215

Antibodies for human use, monoclonal ................................ 753Anticoagulant and preservative solutions for human blood................................................................................................ 1572

Anticomplementary activity of immunoglobulin (2.6.17.).. 200Anti-D antibodies in human immunoglobulin, test for(2.6.26.) .................................................................................... 215

Anti-D immunoglobulin for intravenous administration,human .................................................................................... 2407

Anti-D immunoglobulin, human ......................................... 2406Anti-D immunoglobulin, human, assay of (2.7.13.) ............ 249Antimicrobial preservation, efficacy of (5.1.3.) .................... 557Antiserum, European viper venom ...................................... 1033Antithrombin III concentrate, human................................. 2407Antithrombin III, human, assay of (2.7.17.) ......................... 254Anti-T lymphocyte immunoglobulin for human use,animal .................................................................................... 1575

Apomorphine hydrochloride hemihydrate ......................... 1578Apparatus (2.1.) .......................................................................... 15Apparent dissolution (2.9.43.)................................................. 361Application of the F0 concept to steam sterilisation of aqueouspreparations (5.1.5.) ............................................................... 560

Aprotinin ................................................................................. 1579Aprotinin concentrated solution .......................................... 1581Arachis oil, hydrogenated...................................................... 1584Arachis oil, refined ................................................................. 1584Arginine ................................................................................... 1585

Arginine aspartate .................................................................. 1586Arginine hydrochloride ......................................................... 1586Argon ....................................................................................... 1587Aristolochic acids in herbal drugs, test for (2.8.21) ............. 279Arnica flower........................................................................... 1151Arnica tincture........................................................................ 1153Arsenic (2.4.2.) .......................................................................... 127Arsenious trioxide for homoeopathic preparations ........... 1443Articaine hydrochloride......................................................... 1588Artichoke leaf .......................................................................... 1154Artichoke leaf dry extract ...................................................... 1156Ascorbate, calcium ................................................................. 1731Ascorbate, sodium.................................................................. 3229Ascorbic acid ........................................................................... 1590Ascorbyl palmitate.................................................................. 1591Ash insoluble in hydrochloric acid (2.8.1.) ........................... 271Ash leaf .................................................................................... 1157Ash, sulfated (2.4.14.)............................................................... 132Ash, sulfated (2.4.14.) (5.8.) .................................................... 678Ash, total (2.4.16.) .................................................................... 132Asparagine monohydrate....................................................... 1592Aspartame................................................................................ 1593Aspartic acid............................................................................ 1594Assay of 1,8-cineole in essential oils (2.8.11.) ....................... 272Assay of diphtheria vaccine (adsorbed) (2.7.6.).................... 237Assay of heparin (2.7.5.) .......................................................... 237Assay of heparin in coagulation factors (2.7.12.) ................. 249Assay of hepatitis A vaccine (2.7.14.)..................................... 251Assay of hepatitis B vaccine (rDNA) (2.7.15.) ...................... 252Assay of human α-1-proteinase inhibitor (2.7.32.) .............. 266Assay of human anti-D immunoglobulin (2.7.13.) .............. 249Assay of human antithrombin III (2.7.17.)............................ 254Assay of human coagulation factor II (2.7.18.)..................... 254Assay of human coagulation factor IX (2.7.11.) ................... 248Assay of human coagulation factor VII (2.7.10.).................. 247Assay of human coagulation factor VIII (2.7.4.) .................. 236Assay of human coagulation factor X (2.7.19.) ..................... 255Assay of human coagulation factor XI (2.7.22.) ................... 258Assay of human plasmin inhibitor (2.7.25.) .......................... 261Assay of human protein C (2.7.30.)........................................ 265Assay of human protein S (2.7.31.) ........................................ 266Assay of human von Willebrand factor (2.7.21.) .................. 257Assay of interferons (5.6.)........................................................ 663Assay of pertussis vaccine (acellular) (2.7.16.)...................... 252Assay of pertussis vaccine (whole cell) (2.7.7.) ..................... 242Assay of poliomyelitis vaccine (inactivated), in vivo(2.7.20.) .................................................................................... 255

Assay of tetanus vaccine (adsorbed) (2.7.8.) ......................... 242Assays (2.5.)............................................................................... 155Astragalus mongholicus root ................................................ 1158Atenolol.................................................................................... 1595Atomic absorption spectrometry (2.2.23.) .............................. 36Atomic emission spectrometry (2.2.22.).................................. 35Atomic emission spectrometry, inductively coupled plasma-(2.2.57.) ...................................................................................... 97

Atomoxetine hydrochloride .................................................. 1596Atorvastatin calcium trihydrate ............................................ 1598Atovaquone.............................................................................. 1600Atractylodes lancea rhizome ................................................. 1159Atractylodes rhizome, largehead .......................................... 1160Atracurium besilate ................................................................ 1601Atropine ................................................................................... 1604Atropine sulfate....................................................................... 1605Aujeszky’s disease vaccine (inactivated) for pigs .................. 921Aujeszky’s disease vaccine (live) for pigs for parenteraladministration......................................................................... 923

Aurothiomalate, sodium........................................................ 3230Avian infectious bronchitis vaccine (inactivated)................. 925Avian infectious bronchitis vaccine (live).............................. 926Avian infectious bursal disease vaccine (inactivated) .......... 928Avian infectious bursal disease vaccine (live) ....................... 929Avian infectious encephalomyelitis vaccine (live) ................ 931Avian infectious laryngotracheitis vaccine (live).................. 932



Avian live virus vaccines : tests for extraneous agents in batchesof finished product (2.6.25.).................................................. 212

Avian paramyxovirus 1 (Newcastle disease) vaccine(inactivated) ............................................................................ 995

Avian paramyxovirus 1 (Newcastle disease) vaccine (live).. 997Avian paramyxovirus 3 vaccine (inactivated) for turkeys ... 934Avian tuberculin purified protein derivative....................... 3493Avian viral tenosynovitis vaccine (live) ................................. 935Avian viral vaccines : tests for extraneous agents in seed lots(2.6.24.) .................................................................................... 209

Azaperone for veterinary use ................................................ 1607Azathioprine............................................................................ 1608Azelastine hydrochloride ....................................................... 1609Azithromycin .......................................................................... 1610

BB19 virus (B19V), validation of nucleic acid amplificationtechniques for the quantification of B19V DNA in plasmapools : guidelines..................................................................... 204

Bacampicillin hydrochloride ................................................. 1615Bacitracin................................................................................. 1617Bacitracin zinc......................................................................... 1619Baclofen ................................................................................... 1621Bacterial endotoxins (2.6.14.).................................................. 194Bacterial endotoxins, guidelines for using the test for(5.1.10.) .................................................................................... 572

Baical skullcap root ................................................................ 1161Bambuterol hydrochloride .................................................... 1622Barbados aloes ........................................................................ 1140Barbital..................................................................................... 1623Barium chloride dihydrate for homoeopathicpreparations .......................................................................... 1444

Barium sulfate ......................................................................... 1624Basic butylated methacrylate copolymer ............................. 1624BCG for immunotherapy......................................................... 818BCG vaccine, freeze-dried....................................................... 819Bearberry leaf .......................................................................... 1162Beclometasone dipropionate, anhydrous............................. 1626Beclometasone dipropionate monohydrate......................... 1628Bee for homoeopathic preparations, honey ........................ 1449Beeswax, white ........................................................................ 1630Beeswax, yellow....................................................................... 1630Belamcanda chinensis rhizome............................................. 1163Belladonna leaf........................................................................ 1165Belladonna leaf dry extract, standardised ........................... 1166Belladonna leaf tincture, standardised................................. 1167Belladonna, prepared ............................................................. 1168Benazepril hydrochloride ...................................................... 1631Bendroflumethiazide.............................................................. 1633Benperidol ............................................................................... 1633Benserazide hydrochloride .................................................... 1635Bentonite.................................................................................. 1636Benzalkonium chloride.......................................................... 1637Benzalkonium chloride solution........................................... 1638Benzathine benzylpenicillin .................................................. 1647Benzbromarone....................................................................... 1640Benzethonium chloride ......................................................... 1641Benzocaine............................................................................... 1642Benzoic acid ............................................................................ 1643Benzoin, Siam ......................................................................... 1169Benzoin, Siam ......................................................................... 1169Benzoin, Sumatra.................................................................... 1170Benzoin tincture, Siam........................................................... 1171Benzoin tincture, Sumatra..................................................... 1172Benzoyl peroxide, hydrous .................................................... 1643Benzyl alcohol ......................................................................... 1645Benzyl benzoate ...................................................................... 1646Benzylpenicillin, benzathine ................................................. 1647Benzylpenicillin potassium ................................................... 1648Benzylpenicillin, procaine ..................................................... 1650Benzylpenicillin sodium ........................................................ 1651Betacarotene ............................................................................ 1653

Betacyclodextrin ..................................................................... 1653Betacyclodextrin, poly(hydroxypropyl) ether ..................... 2456Betadex..................................................................................... 1653Betahistine dihydrochloride.................................................. 1655Betahistine mesilate................................................................ 1656Betamethasone........................................................................ 1657Betamethasone acetate ........................................................... 1659Betamethasone dipropionate................................................. 1661Betamethasone sodium phosphate....................................... 1663Betamethasone valerate ......................................................... 1664Betaxolol hydrochloride......................................................... 1666Bezafibrate ............................................................................... 1667Bicalutamide............................................................................ 1668Bifonazole ................................................................................ 1670Bilberry fruit, dried ................................................................ 1172Bilberry fruit dry extract, fresh, refined and standardised.. 1250Bilberry fruit, fresh................................................................. 1173Biological assays (2.7.) ............................................................. 229Biological assays and tests, statistical analysis of results of(5.3.) ......................................................................................... 607

Biological indicators of sterilisation (5.1.2.).......................... 556Biological products, general texts on (5.2.) ........................... 579Biological products, terminology used in monographs on(5.2.1.) ...................................................................................... 579

Biological tests (2.6.) ................................................................ 175Biotin........................................................................................ 1671Biperiden hydrochloride........................................................ 1672Biphasic insulin injection ...................................................... 2493Biphasic isophane insulin injection...................................... 2493Birch leaf .................................................................................. 1173Bisacodyl .................................................................................. 1673Bismuth subcarbonate............................................................ 1675Bismuth subgallate.................................................................. 1676Bismuth subnitrate, heavy ..................................................... 1676Bismuth subsalicylate ............................................................. 1677Bisoprolol fumarate ................................................................ 1678Bistort rhizome ....................................................................... 1175Bitter fennel ............................................................................. 1241Bitter-fennel fruit oil .............................................................. 1176Bitter-fennel herb oil .............................................................. 1177Bitterness value (2.8.15.) .......................................................... 276Bitter-orange epicarp and mesocarp .................................... 1179Bitter-orange-epicarp and mesocarp tincture..................... 1180Bitter-orange flower................................................................ 1181Bitter-orange-flower oil.......................................................... 1329Black cohosh............................................................................ 1182Blackcurrant leaf ..................................................................... 1186Black horehound..................................................................... 1185Bleomycin sulfate.................................................................... 1680Blood and blood components, empty sterile containers ofplasticised poly(vinyl chloride) for (3.2.4.) ......................... 417

Blood and blood components, human, materials for containersfor (3.1.1.) ................................................................................ 375

Blood and blood components, sets for the transfusion of(3.2.6.) ...................................................................................... 418

Blood and blood components, sterile plastic containers for(3.2.3.) ...................................................................................... 415

Blood, anticoagulant and preservative solutions for .......... 1572Blood, sterile containers of plasticised poly(vinyl chloride)containing anticoagulant solution (3.2.5.)........................... 418

Bogbean leaf ............................................................................ 1187Boiling point (2.2.12.) ................................................................ 31Boldo leaf ................................................................................. 1188Boldo leaf dry extract............................................................. 1189Borage (starflower) oil, refined ............................................. 1681Borax ........................................................................................ 1682Bordetella bronchiseptica vaccine (live) for dogs................. 936Boric acid................................................................................. 1682Botulinum antitoxin ............................................................... 1029Botulinum toxin type A for injection .................................. 1683Botulinum toxin type B for injection................................... 1684Bovine insulin ......................................................................... 2486Bovine leptospirosis vaccine (inactivated) ............................ 937



Bovine parainfluenza virus vaccine (live).............................. 938Bovine respiratory syncytial virus vaccine (live) .................. 940Bovine rhinotracheitis vaccine (live), infectious .................. 983Bovine serum .......................................................................... 1686Bovine tuberculin purified protein derivative..................... 3494Bovine viral diarrhoea vaccine (inactivated) ........................ 941Bromazepam ........................................................................... 1687Bromhexine hydrochloride.................................................... 1688Bromocriptine mesilate.......................................................... 1689Bromperidol ............................................................................ 1692Bromperidol decanoate.......................................................... 1693Brompheniramine maleate .................................................... 1695Bronchitis vaccine (inactivated), infectious, avian ............... 925Bronchitis vaccine (live), infectious, avian ............................ 926Brotizolam ............................................................................... 1696Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) forveterinary use.......................................................................... 942

Buccal tablets and sublingual tablets...................................... 795Buckwheat herb ...................................................................... 1190Budesonide .............................................................................. 1697Bufexamac ............................................................................... 1699Buffer solutions (4.1.3.)............................................................ 540Buflomedil hydrochloride...................................................... 1700Bulk density and tapped density of powders (2.9.34.) ......... 343Bumetanide ............................................................................. 1702Bupivacaine hydrochloride.................................................... 1703Buprenorphine ........................................................................ 1705Buprenorphine hydrochloride .............................................. 1706Bursal disease vaccine (inactivated), infectious, avian......... 928Bursal disease vaccine (live), infectious, avian...................... 929Buserelin .................................................................................. 1708Buspirone hydrochloride ....................................................... 1709Busulfan ................................................................................... 1711Butcher’s broom...................................................................... 1192Butylated methacrylate copolymer, basic ............................ 1624Butylhydroxyanisole ............................................................... 1713Butylhydroxytoluene .............................................................. 1714Butyl parahydroxybenzoate................................................... 1712

CCabergoline ............................................................................. 1717Cachets....................................................................................... 781Cadmium sulfate hydrate for homoeopathic prepara-tions........................................................................................ 1444

Caffeine .................................................................................... 1718Caffeine monohydrate............................................................ 1719Calcifediol................................................................................ 1720Calcipotriol, anhydrous ......................................................... 1722Calcipotriol monohydrate ..................................................... 1724Calcitonin (salmon)................................................................ 1726Calcitriol .................................................................................. 1728Calcium (2.4.3.)......................................................................... 127Calcium acetate, anhydrous .................................................. 1729Calcium ascorbate .................................................................. 1731Calcium carbonate.................................................................. 1731Calcium carboxymethylcellulose .......................................... 1774Calcium chloride dihydrate................................................... 1732Calcium chloride hexahydrate .............................................. 1733Calcium dobesilate monohydrate ......................................... 1733Calcium edetate, sodium ....................................................... 3233Calcium folinate...................................................................... 1734Calcium glucoheptonate ........................................................ 1736Calcium gluconate .................................................................. 1737Calcium gluconate, anhydrous.............................................. 1738Calcium gluconate for injection ........................................... 1739Calcium glycerophosphate .................................................... 1740Calcium hydrogen phosphate, anhydrous ........................... 1740Calcium hydrogen phosphate dihydrate.............................. 1742Calcium hydroxide ................................................................. 1743Calcium in adsorbed vaccines (2.5.14.) ................................. 159Calcium iodide tetrahydrate for homoeopathicpreparations .......................................................................... 1444

Calcium lactate, anhydrous ................................................... 1743Calcium lactate monohydrate ............................................... 1744Calcium lactate pentahydrate................................................ 1744Calcium lactate trihydrate ..................................................... 1745Calcium levofolinate pentahydrate....................................... 1745Calcium levulinate dihydrate ................................................ 1748Calcium pantothenate ............................................................ 1749Calcium pentetate (sodium) for radiopharmaceuticalpreparations .......................................................................... 1075

Calcium phosphate ................................................................. 1749Calcium stearate ..................................................................... 1750Calcium sulfate dihydrate...................................................... 1751Calendula flower..................................................................... 1193Calf coronavirus diarrhoea vaccine (inactivated)................. 943Calf rotavirus diarrhoea vaccine (inactivated)...................... 944Calicivirosis vaccine (inactivated), feline .............................. 970Calicivirosis vaccine (live), feline ........................................... 971Camphor, D-............................................................................ 1752Camphor, racemic .................................................................. 1753Candesartan cilexetil .............................................................. 1754Canine adenovirus vaccine (inactivated)............................... 945Canine adenovirus vaccine (live)............................................ 946Canine distemper vaccine (live) ............................................. 947Canine leptospirosis vaccine (inactivated) ............................ 948Canine parainfluenza virus vaccine (live) ............................. 949Canine parvovirosis vaccine (inactivated)............................. 950Canine parvovirosis vaccine (live).......................................... 951Cape aloes................................................................................ 1141Capillary electrophoresis (2.2.47.) ............................................ 79Capillary electrophoresis (2.2.47.) (5.8.) ............................... 677Capillary viscometer method (2.2.9.)....................................... 27Caprylate, sodium................................................................... 3234Caprylic acid ........................................................................... 1756Caprylocaproyl macrogolglycerides ..................................... 1757Capsicum ................................................................................. 1194Capsicum oleoresin, refined and standardised ................... 1196Capsicum soft extract, standardised .................................... 1197Capsicum tincture, standardised .......................................... 1198Capsules ..................................................................................... 779Capsules and tablets, disintegration of (2.9.1.) ..................... 285Capsules and tablets, disintegration of (2.9.1.) (5.8.)........... 678Capsules, gastro-resistant ........................................................ 780Capsules, hard ........................................................................... 780Capsules, intrauterine .............................................................. 787Capsules, modified-release ...................................................... 780Capsules, oromucosal............................................................... 795Capsules, rectal ......................................................................... 806Capsules, soft............................................................................. 780Capsules, vaginal....................................................................... 813Captopril .................................................................................. 1758Caraway fruit........................................................................... 1199Caraway oil .............................................................................. 1200Carbachol................................................................................. 1760Carbamazepine ....................................................................... 1761Carbasalate calcium................................................................ 1762Carbidopa ................................................................................ 1764Carbimazole ............................................................................ 1765Carbocisteine........................................................................... 1766Carbomers ............................................................................... 1766Carbon dioxide ....................................................................... 1768Carbon dioxide in gases (2.5.24.) ........................................... 161Carbon monoxide................................................................... 1769Carbon monoxide (15O) ......................................................... 1048Carbon monoxide in gases (2.5.25.)....................................... 162Carboplatin.............................................................................. 1770Carboprost trometamol ......................................................... 1771Carboxymethylcellulose......................................................... 1773Carboxymethylcellulose calcium.......................................... 1774Carboxymethylcellulose sodium........................................... 1774Carboxymethylcellulose sodium, cross-linked ................... 1969Carboxymethylcellulose sodium, low-substituted.............. 1775Carisoprodol............................................................................ 1772Carmellose............................................................................... 1773



Carmellose calcium ................................................................ 1774Carmellose sodium................................................................. 1774Carmellose sodium and microcrystalline cellulose............ 2776Carmellose sodium, low-substituted.................................... 1775Carmustine .............................................................................. 1776Carnauba wax.......................................................................... 1777Carprofen for veterinary use ................................................. 1778Carrageenan ............................................................................ 1779Carteolol hydrochloride......................................................... 1780Carvedilol ................................................................................ 1781Cascara..................................................................................... 1201Cascara dry extract, standardised......................................... 1202Cassia oil .................................................................................. 1203Castor oil, hydrogenated........................................................ 1782Castor oil, polyoxyl................................................................. 2665Castor oil, polyoxyl hydrogenated........................................ 2664Castor oil, refined ................................................................... 1783Castor oil, virgin ..................................................................... 1784Catgut, sterile .......................................................................... 1117Catgut, sterile, in distributor for veterinary use ................. 1127CD34/CD45+ cells in haematopoietic products, numerationof (2.7.23.)................................................................................ 258

Cefaclor.................................................................................... 1785Cefadroxil monohydrate........................................................ 1786Cefalexin monohydrate.......................................................... 1788Cefalotin sodium .................................................................... 1789Cefamandole nafate................................................................ 1791Cefapirin sodium.................................................................... 1792Cefatrizine propylene glycol.................................................. 1793Cefazolin sodium.................................................................... 1794Cefepime dihydrochloride monohydrate ............................ 1796Cefixime................................................................................... 1799Cefoperazone sodium ............................................................ 1800Cefotaxime sodium ................................................................ 1801Cefoxitin sodium .................................................................... 1803Cefpodoxime proxetil ............................................................ 1805Cefprozil monohydrate .......................................................... 1807Cefradine ................................................................................. 1809Ceftazidime pentahydrate...................................................... 1811Ceftazidime pentahydrate with sodium carbonate forinjection ................................................................................. 1813

Ceftriaxone sodium................................................................ 1815Cefuroxime axetil ................................................................... 1817Cefuroxime sodium................................................................ 1818Celandine, greater................................................................... 1268Celecoxib ................................................................................. 1819Celiprolol hydrochloride ....................................................... 1820Cell count and viability, nucleated (2.7.29.).......................... 263Cell cultures for the production of veterinary vaccines(5.2.4.) ...................................................................................... 585

Cell substrates for the production of vaccines for human use(5.2.3.) ...................................................................................... 582

Cellular products, microbiological control of (2.6.27.)........ 216Cellulose acetate ..................................................................... 1822Cellulose acetate butyrate ...................................................... 1823Cellulose acetate phthalate .................................................... 1823Cellulose, microcrystalline .................................................... 1824Cellulose (microcrystalline) and carmellose sodium......... 2776Cellulose, powdered ............................................................... 1828Centaury .................................................................................. 1204Centella .................................................................................... 1205Cetirizine dihydrochloride .................................................... 1831Cetostearyl alcohol ................................................................. 1833Cetostearyl alcohol (type A), emulsifying ........................... 1834Cetostearyl alcohol (type B), emulsifying ........................... 1835Cetostearyl isononanoate ...................................................... 1836Cetostearyl sulfate, sodium ................................................... 3237Cetrimide................................................................................. 1836Cetyl alcohol............................................................................ 1837Cetyl palmitate ........................................................................ 1838Cetylpyridinium chloride ...................................................... 1838Ceylon cinnamon bark oil ..................................................... 1210Ceylon cinnamon leaf oil....................................................... 1211

CFC assay for human haematopoietic progenitor cells(2.7.28.) .................................................................................... 262

Chamomile flower, Roman ................................................... 1206Characterisation of crystalline and partially crystalline solidsby X-ray powder diffraction (XRPD) (2.9.33.) ................... 339

Characterisation of crystalline solids by microcalorimetry andsolution calorimetry (2.2.61.)................................................ 106

Characterisation of preparations for nebulisation (2.9.44.).. 363Characters section in monographs (5.11.) ............................ 695Charcoal, activated ................................................................. 1839Chenodeoxycholic acid ......................................................... 1840Chewable tablets ....................................................................... 811Chewing gums, medicated ...................................................... 781Chewing gums, medicated, dissolution test for (2.9.25.)..... 325Chicken anaemia vaccine (live), infectious ........................... 984Chicken flocks free from specified pathogens for theproduction and quality control of vaccines (5.2.2.) ........... 579

Chitosan hydrochloride ......................................................... 1841Chlamydiosis vaccine (inactivated), feline ........................... 972Chloral hydrate ....................................................................... 1842Chlorambucil .......................................................................... 1843Chloramine.............................................................................. 3450Chloramphenicol .................................................................... 1844Chloramphenicol palmitate................................................... 1845Chloramphenicol sodium succinate..................................... 1846Chlorcyclizine hydrochloride................................................ 1847Chlordiazepoxide.................................................................... 1848Chlordiazepoxide hydrochloride .......................................... 1849Chlorhexidine diacetate ......................................................... 1850Chlorhexidine digluconate solution ..................................... 1851Chlorhexidine dihydrochloride ............................................ 1854Chlorides (2.4.4.) ...................................................................... 127Chlorobutanol, anhydrous..................................................... 1855Chlorobutanol hemihydrate .................................................. 1855Chlorocresol ............................................................................ 1856Chloroquine phosphate ......................................................... 1857Chloroquine sulfate ................................................................ 1857Chlorphenamine maleate ...................................................... 1858Chlorpromazine hydrochloride ............................................ 1859Chlorpropamide ..................................................................... 1861Chlorprothixene hydrochloride ............................................ 1862Chlortalidone .......................................................................... 1863Chlortetracycline hydrochloride........................................... 1865Cholecalciferol ........................................................................ 1867Cholecalciferol concentrate (oily form)............................... 1869Cholecalciferol concentrate (powder form) ........................ 1870Cholecalciferol concentrate (water-dispersible form)........ 1872Cholera vaccine......................................................................... 821Cholera vaccine, freeze-dried.................................................. 821Cholera vaccine (inactivated), fowl ........................................ 980Cholera vaccine (inactivated, oral)......................................... 822Cholesterol............................................................................... 1873Cholesterol for parenteral use ............................................... 1874Cholesterol in oils rich in omega-3 acids, total (2.4.32.) ..... 151Chondroitin sulfate sodium .................................................. 1876Chromatographic separation techniques (2.2.46.) ................. 72Chromatography, gas (2.2.28.).................................................. 43Chromatography, liquid (2.2.29.) ............................................. 45Chromatography, paper (2.2.26.) ............................................. 42Chromatography, size-exclusion (2.2.30.) ............................... 46Chromatography, supercritical fluid (2.2.45.)......................... 72Chromatography, thin-layer (2.2.27.) ...................................... 42Chromium (51Cr) edetate injection ...................................... 1049Chymotrypsin ......................................................................... 1878Ciclesonide .............................................................................. 1879Ciclopirox ................................................................................ 1880Ciclopirox olamine ................................................................. 1881Ciclosporin .............................................................................. 1883Cilastatin sodium.................................................................... 1884Cilazapril.................................................................................. 1885Cimetidine ............................................................................... 1887Cimetidine hydrochloride ..................................................... 1888Cinchocaine hydrochloride ................................................... 1890



Cinchona bark......................................................................... 1207Cinchona liquid extract, standardised ................................. 1208Cineole ..................................................................................... 1891Cineole in essential oils, 1,8-, assay of (2.8.11.) .................... 272Cineole type niaouli oil.......................................................... 1332Cinnamon................................................................................ 1209Cinnamon bark oil, Ceylon................................................... 1210Cinnamon leaf oil, Ceylon..................................................... 1211Cinnamon tincture ................................................................. 1212Cinnarizine.............................................................................. 1892Ciprofibrate ............................................................................. 1893Ciprofloxacin........................................................................... 1894Ciprofloxacin hydrochloride ................................................. 1896Circular dichroism (2.2.41.) ...................................................... 67Cisplatin................................................................................... 1897Citalopram hydrobromide..................................................... 1899Citalopram hydrochloride ..................................................... 1900Citric acid, anhydrous............................................................ 1901Citric acid monohydrate ........................................................ 1902Citronella oil............................................................................ 1212Cladribine ................................................................................ 1903Clarithromycin........................................................................ 1904Clarity and degree of opalescence of liquids (2.2.1.).............. 21Clary sage oil ........................................................................... 1213Classical swine-fever vaccine (live, prepared in cellcultures) ................................................................................. 1019

Clazuril for veterinary use..................................................... 1906Clebopride malate .................................................................. 1908Clemastine fumarate .............................................................. 1909Clematis armandii stem......................................................... 1214Clenbuterol hydrochloride .................................................... 1911Clindamycin hydrochloride .................................................. 1912Clindamycin phosphate ......................................................... 1913Clioquinol................................................................................ 1914Clobazam................................................................................. 1915Clobetasol propionate ............................................................ 1916Clobetasone butyrate.............................................................. 1918Clodronate disodium tetrahydrate ....................................... 1919Clofazimine ............................................................................. 1920Clofibrate ................................................................................. 1921Clomifene citrate .................................................................... 1922Clomipramine hydrochloride ............................................... 1924Clonazepam............................................................................. 1925Clonidine hydrochloride........................................................ 1926Clopamide ............................................................................... 1927Clopidogrel hydrogen sulfate ................................................ 1928Clorazepate, dipotassium....................................................... 2077Closantel sodium dihydrate for veterinary use................... 1930Clostridium botulinum vaccine for veterinary use .............. 952Clostridium chauvoei vaccine for veterinary use ................. 953Clostridium novyi alpha antitoxin for veterinary use........ 1037Clostridium novyi (type B) vaccine for veterinary use........ 954Clostridium perfringens beta antitoxin for veterinary use................................................................................................ 1038

Clostridium perfringens epsilon antitoxin for veterinaryuse........................................................................................... 1039

Clostridium perfringens vaccine for veterinary use............. 955Clostridium septicum vaccine for veterinary use................. 957Closures and containers for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.) ......... 388

Closures and containers for pharmaceutical use, plastic(3.2.2.) ...................................................................................... 414

Closures and tubing, silicone elastomer for (3.1.9.) ............. 394Closures for containers for aqueous parenteral preparations,for powders and for freeze-dried powders, rubber(3.2.9.) ...................................................................................... 421

Clotrimazole............................................................................ 1931Clove......................................................................................... 1215Clove oil ................................................................................... 1216Cloxacillin sodium ................................................................. 1933Clozapine ................................................................................. 1934Coagulation factor II, assay of (2.7.18.) ................................. 254Coagulation factor IX, human .............................................. 2416

Coagulation factor IX, human, assay of (2.7.11.) ................. 248Coagulation factors, activated (2.6.22.) ................................. 209Coagulation factors, assay of heparin (2.7.12.) ..................... 249Coagulation factor VIIa (rDNA) concentrated solution,human .................................................................................... 2410

Coagulation factor VII, human ............................................ 2408Coagulation factor VII, human, assay of (2.7.10.)................ 247Coagulation factor VIII, human........................................... 2414Coagulation factor VIII, human, assay of (2.7.4.) ................ 236Coagulation factor VIII (rDNA), human ............................ 2415Coagulation factor X, assay of (2.7.19.) ................................. 255Coagulation factor XI, human .............................................. 2417Coagulation factor XI, human, assay of (2.7.22.) ................. 258Coated granules ........................................................................ 786Coated tablets............................................................................ 810Cocaine hydrochloride........................................................... 1935Coccidiosis vaccine (live) for chickens .................................. 959Coconut oil, refined................................................................ 1936Cocoyl caprylocaprate............................................................ 1937Codeine.................................................................................... 1938Codeine hydrochloride dihydrate......................................... 1939Codeine phosphate hemihydrate .......................................... 1941Codeine phosphate sesquihydrate ........................................ 1942Codergocrine mesilate ........................................................... 1944Cod-liver oil, farmed.............................................................. 1946Cod-liver oil (type A)............................................................. 1950Cod-liver oil (type B) ............................................................. 1954Coix seed.................................................................................. 1217Cola .......................................................................................... 1218Colchicine................................................................................ 1957Cold-water vibriosis vaccine (inactivated) for salmonids.. 1023Colestyramine ......................................................................... 1959Colibacillosis vaccine (inactivated), neonatal piglet ............ 992Colibacillosis vaccine (inactivated), neonatal ruminant...... 994Colistimethate sodium........................................................... 1960Colistin sulfate ........................................................................ 1961Colloidal anhydrous silica ..................................................... 3218Colloidal hydrated silica ........................................................ 3219Colloidal silica, hydrophobic ................................................ 3220Colloidal silver, for external use ........................................... 3221Colony-forming cell assay for human haematopoieticprogenitor cells (2.7.28.) ........................................................ 262

Colophony ............................................................................... 1219Coloration of liquids (2.2.2.) ..................................................... 22Common selfheal fruit-spike ................................................ 1219Common stinging nettle for homoeopathic preparations.. 1445Comparative table of porosity of sintered-glass filters(2.1.2.) ........................................................................................ 15

Complexometric titrations (2.5.11.) ....................................... 158Composition of fatty acids by gas chromatography(2.4.22.) .................................................................................... 136

Composition of fatty acids in oils rich in omega-3 acids(2.4.29.) .................................................................................... 148

Compressed lozenges ............................................................... 795Concentrated solutions for haemodialysis .......................... 2376Concentrates for injections or infusions................................ 797Concentrates for intrauterine solutions ................................. 787Conductivity (2.2.38.) ................................................................ 59Coneflower herb, purple ........................................................ 1357Coneflower root, narrow-leaved ........................................... 1327Coneflower root, pale............................................................. 1345Coneflower root, purple......................................................... 1359Conjugated estrogens ............................................................. 2174Consistency by penetrometry, measurement of (2.9.9.) ...... 299Containers (3.2.) ....................................................................... 409Containers and closures for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.) ......... 388

Containers and closures for pharmaceutical use, plastic(3.2.2.) ...................................................................................... 414

Containers and tubing for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.)..... 391

Containers for aqueous solutions for infusion, plastic(3.2.2.1.) ................................................................................... 414



Containers for aqueous solutions for intravenous infusion,materials based on plasticised poly(vinyl chloride) for(3.1.14.) .................................................................................... 401

Containers for dry dosage forms for oral administration,materials based on non-plasticised poly(vinyl chloride) for(3.1.11.) .................................................................................... 397

Containers for human blood and blood components, materialsbased on plasticised poly(vinyl chloride) for (3.1.1.1.)...... 375

Containers for human blood and blood components, materialsfor (3.1.1.) ................................................................................ 375

Containers for human blood and blood components, plastic,sterile (3.2.3.)........................................................................... 415

Containers for non-injectable aqueous solutions, materialsbased on non-plasticised poly(vinyl chloride) for(3.1.10.) .................................................................................... 395

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene with additives for (3.1.5.)........ 384

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene without additives for (3.1.4.) .. 383

Containers for pharmaceutical use, glass (3.2.1.) ................. 409Containers for preparations not for parenteral use,polyethylene terephthalate for (3.1.15) ................................ 403

Containers, materials used for the manufacture of (3.1.).... 375Containers of plasticised poly(vinyl chloride) for human bloodand blood components, empty sterile (3.2.4.)..................... 417

Containers of plasticised poly(vinyl chloride) for human bloodcontaining anticoagulant solution, sterile (3.2.5.) .............. 418

Contamination, microbial : microbial enumeration tests(2.6.12.) .................................................................................... 185

Contamination, microbial : microbial enumeration tests(2.6.12.) (5.8.).......................................................................... 678

Contamination, microbial : test for specified micro-organisms(2.6.13.) .................................................................................... 189

Contamination, microbial : test for specified micro-organisms(2.6.13.) (5.8.).......................................................................... 678

Content uniformity of single-dose preparations (2.9.6.) ..... 298Control of impurities in substances for pharmaceutical use(5.10.) ....................................................................................... 689

Control of microbiological quality, alternative methods for(5.1.6.) ...................................................................................... 560

Copolymer, basic butylated methacrylate ........................... 1624Copolymer, grafted, macrogol poly(vinyl alcohol) ............ 2660Copolymer, methacrylic acid - ethyl acrylate (1:1) ............ 2727Copolymer, methacrylic acid - ethyl acrylate (1:1) dispersion30 per cent ............................................................................. 2728

Copolymer, methacrylic acid - methyl methacrylate(1:1) ........................................................................................ 2729

Copolymer, methacrylic acid - methyl methacrylate(1:2) ........................................................................................ 2730

Copolymer (type A), ammonio methacrylate..................... 1549Copolymer (type B), ammonio methacrylate ..................... 1550Copovidone ............................................................................. 1962Copper acetate monohydrate for homoeopathicpreparations .......................................................................... 1446

Copper for homoeopathic preparations .............................. 1446Copper sulfate, anhydrous..................................................... 1964Copper sulfate pentahydrate ................................................. 1965Coriander................................................................................. 1220Coriander oil ........................................................................... 1221Coronavirus diarrhoea vaccine (inactivated), calf ............... 943Cortisone acetate .................................................................... 1965Cotton, absorbent ................................................................... 1967Cottonseed oil, hydrogenated .............................................. 1968Couch grass rhizome.............................................................. 1222Creams ....................................................................................... 808Cresol, crude ........................................................................... 1968Cromoglicate, sodium............................................................ 3240Croscarmellose sodium ......................................................... 1969Crospovidone .......................................................................... 1970Crotamiton .............................................................................. 1971Crystalline and partially crystalline solids, characterisationby X-ray powder diffraction (XRPD) of (2.9.33.)............... 339

Crystalline solids, characterisation by microcalorimetry andsolution calorimetry (2.2.61.)................................................ 106

Crystallinity (5.16.)................................................................... 723Cutaneous application, liquid preparations for .................... 789Cutaneous application, powders for....................................... 799Cutaneous application, semi-solid preparations for ............ 807Cutaneous application, veterinary liquid preparations for.. 814Cutaneous foams ...................................................................... 790Cutaneous patches .................................................................... 807Cyanocobalamin ..................................................................... 1973Cyanocobalamin (57Co) capsules .......................................... 1049Cyanocobalamin (57Co) solution .......................................... 1050Cyanocobalamin (58Co) capsules .......................................... 1051Cyanocobalamin (58Co) solution .......................................... 1051Cyclamate, sodium ................................................................. 3241Cyclizine hydrochloride......................................................... 1974Cyclopentolate hydrochloride ............................................... 1975Cyclophosphamide ................................................................. 1976Cyproheptadine hydrochloride............................................. 1977Cyproterone acetate................................................................ 1978Cysteine hydrochloride monohydrate.................................. 1980Cystine ..................................................................................... 1981Cytarabine ............................................................................... 1982

DDacarbazine............................................................................. 1987Dalteparin sodium.................................................................. 1988Danaparoid sodium................................................................ 1990Dandelion herb with root ...................................................... 1223Dandelion root........................................................................ 1224Dapsone ................................................................................... 1992Daunorubicin hydrochloride ................................................ 1993D-Camphor.............................................................................. 1752Decyl oleate ............................................................................. 1994Deferoxamine mesilate........................................................... 1994Degree of coloration of liquids (2.2.2.) .................................... 22Dembrexine hydrochloride monohydrate for veterinaryuse........................................................................................... 1995

Demeclocycline hydrochloride ............................................. 1996Demonstration of uniformity of dosage units using largesample sizes (2.9.47.).............................................................. 368

Density of powders, bulk density and tapped (2.9.34.)........ 343Density of solids (2.2.42.) .......................................................... 68Density of solids, gas pycnometric (2.9.23.).......................... 324Density, relative (2.2.5.) ............................................................. 25Dental type silica .................................................................... 3219Depressor substances (2.6.11.) ................................................ 185Deptropine citrate................................................................... 1998Dequalinium chloride ............................................................ 1999Desacyl-4′-monophosphoryl lipid A, 3-O- ......................... 2000Desflurane................................................................................ 2002Desipramine hydrochloride................................................... 2003Deslanoside ............................................................................. 2004Desloratadine .......................................................................... 2005Desmopressin .......................................................................... 2006Desogestrel .............................................................................. 2007Desoxycortone acetate ........................................................... 2008Detection and measurement of radioactivity (2.2.66.) ........ 110Detector tubes, gas (2.1.6.) ........................................................ 17Determination of aflatoxin B1 in herbal drugs (2.8.18.) ...... 276Determination of metal catalyst or metal reagent residues(2.4.20.) .................................................................................... 133

Determination of nitrogen by sulfuric acid digestion(2.5.9.) ...................................................................................... 157

Determination of primary aromatic amino-nitrogen(2.5.8.) ...................................................................................... 157

Determination of water by distillation (2.2.13.) ..................... 31Detomidine hydrochloride for veterinary use .................... 2009Devil’s claw dry extract .......................................................... 1225Devil’s claw root ...................................................................... 1226Dexamethasone....................................................................... 2010Dexamethasone acetate.......................................................... 2012



Dexamethasone isonicotinate ............................................... 2014Dexamethasone sodium phosphate...................................... 2015Dexchlorpheniramine maleate.............................................. 2018Dexpanthenol.......................................................................... 2019Dextran 1 for injection........................................................... 2020Dextran 40 for injection ........................................................ 2021Dextran 60 for injection ........................................................ 2022Dextran 70 for injection ........................................................ 2023Dextranomer ........................................................................... 2023Dextrans, molecular mass distribution in (2.2.39.) ................ 60Dextrin ..................................................................................... 2024Dextromethorphan hydrobromide....................................... 2025Dextromoramide tartrate ...................................................... 2026Dextropropoxyphene hydrochloride.................................... 2027Diacerein.................................................................................. 2028Diazepam................................................................................. 2030Diazoxide ................................................................................. 2031Dibrompropamidine diisetionate ......................................... 2032Dibutyl phthalate .................................................................... 2033Dichloromethane .................................................................... 2743Diclazuril for veterinary use.................................................. 2034Diclofenac potassium ............................................................. 2035Diclofenac sodium.................................................................. 2036Dicloxacillin sodium .............................................................. 2038Dicycloverine hydrochloride................................................. 2039Didanosine .............................................................................. 2040Diethylcarbamazine citrate.................................................... 2042Diethylene glycol and ethylene glycol in ethoxylatedsubstances (2.4.30.)................................................................. 150

Diethylene glycol monoethyl ether ...................................... 2043Diethylene glycol palmitostearate......................................... 2044Diethyl phthalate .................................................................... 2041Diethylstilbestrol..................................................................... 2045Diffraction, laser light, particle size analysis by (2.9.31.) ... 333Difloxacin hydrochloride trihydrate for veterinary use..... 2046Digitalis leaf............................................................................. 1227Digitoxin .................................................................................. 2048Digoxin .................................................................................... 2049Dihydralazine sulfate, hydrated ............................................ 2051Dihydrocodeine hydrogen tartrate ....................................... 2052Dihydroergocristine mesilate ................................................ 2053Dihydroergotamine mesilate................................................. 2056Dihydroergotamine tartrate .................................................. 2058Dihydrostreptomycin sulfate for veterinary use ................. 2059Dihydrotachysterol ................................................................. 2061Diltiazem hydrochloride........................................................ 2062Dimenhydrinate...................................................................... 2063Dimercaprol ............................................................................ 2065Dimethylacetamide ................................................................ 2066Dimethylaniline, N,N- (2.4.26.) .............................................. 146Dimethyl sulfoxide ................................................................. 2066Dimeticone .............................................................................. 2067Dimetindene maleate ............................................................. 2068Dinoprostone .......................................................................... 2070Dinoprost trometamol ........................................................... 2069Diosmin ................................................................................... 2072Dioxan and ethylene oxide (2.4.25.)....................................... 145Dip concentrates ....................................................................... 814Diphenhydramine hydrochloride ......................................... 2073Diphenoxylate hydrochloride................................................ 2074Diphtheria and tetanus toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.)............................................ 261

Diphtheria and tetanus vaccine (adsorbed) .......................... 823Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s)content).................................................................................... 824

Diphtheria antitoxin............................................................... 1029Diphtheria, tetanus and hepatitis B (rDNA) vaccine(adsorbed) ............................................................................... 825

Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed) ................................................................. 826

Diphtheria, tetanus and pertussis (whole cell) vaccine(adsorbed) ............................................................................... 827

Diphtheria, tetanus and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content)............................... 829

Diphtheria, tetanus, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ............ 830

Diphtheria, tetanus, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ............................... 832

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed)................... 834

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ................................................................. 835

Diphtheria, tetanus, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ............ 837

Diphtheria, tetanus, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed) ................................................................. 840

Diphtheria, tetanus, pertussis (whole cell) and poliomyelitis(inactivated) vaccine (adsorbed) .......................................... 842

Diphtheria, tetanus, pertussis (whole cell), poliomyelitis(inactivated) and haemophilus type b conjugate vaccine(adsorbed) ............................................................................... 844

Diphtheria vaccine (adsorbed)................................................ 846Diphtheria vaccine (adsorbed), assay of (2.7.6.)................... 237Diphtheria vaccine (adsorbed, reduced antigen content) ... 847Dipivefrine hydrochloride ..................................................... 2075Dipotassium clorazepate........................................................ 2077Dipotassium phosphate ......................................................... 2078Diprophylline .......................................................................... 2078Dipyridamole .......................................................................... 2079Dirithromycin ......................................................................... 2081Disintegration of suppositories and pessaries (2.9.2.) ......... 287Disintegration of tablets and capsules (2.9.1.) ...................... 285Disintegration of tablets and capsules (2.9.1.) (5.8.)............ 678Disodium clodronate tetrahydrate ....................................... 1919Disodium edetate.................................................................... 2082Disodium etidronate .............................................................. 2195Disodium pamidronate pentahydrate .................................. 2956Disodium phosphate, anhydrous.......................................... 2083Disodium phosphate dihydrate............................................. 2084Disodium phosphate dodecahydrate.................................... 2084Disopyramide.......................................................................... 2085Disopyramide phosphate ....................................................... 2086Dispersible tablets..................................................................... 811Dissolution, apparent (2.9.43.)................................................ 361Dissolution, intrinsic (2.9.29.) ................................................ 331Dissolution test for lipophilic solid dosage forms (2.9.42.).. 361Dissolution test for solid dosage forms (2.9.3.) .................... 288Dissolution test for transdermal patches (2.9.4.).................. 295Dissolution testing, recommendations on (5.17.1.) ............. 727Distemper vaccine (live), canine............................................. 947Distemper vaccine (live) for mustelids .................................. 962Distillation range (2.2.11.) ......................................................... 30Distribution estimation by analytical sieving, particle-size(2.9.38.) .................................................................................... 351

Distribution estimation by analytical sieving, particle-size(2.9.38.) (5.8.).......................................................................... 679

Disulfiram................................................................................ 2087Dithranol ................................................................................. 2088DL-Methionine ........................................................................ 2734DL-α-Tocopheryl hydrogen succinate................................... 3442Dobesilate monohydrate, calcium ........................................ 1733Dobutamine hydrochloride ................................................... 2089Docetaxel, anhydrous............................................................. 2090Docetaxel trihydrate ............................................................... 2092Docusate sodium .................................................................... 2094Dodecyl gallate........................................................................ 2094Dog rose................................................................................... 1228Domperidone .......................................................................... 2095Domperidone maleate............................................................ 2097Dopamine hydrochloride ...................................................... 2098Dopexamine dihydrochloride ............................................... 2099Dorzolamide hydrochloride .................................................. 2101



Dosage forms (glossary) .......................................................... 779Dosage units, demonstration of uniformity using large samplesizes (2.9.47.) ........................................................................... 368

Dosage units, uniformity of (2.9.40.) ..................................... 357Dosulepin hydrochloride....................................................... 2103DOTATOC (gallium (68Ga)) injection ................................. 1062Doxapram hydrochloride ...................................................... 2104Doxazosin mesilate................................................................. 2105Doxepin hydrochloride .......................................................... 2106Doxorubicin hydrochloride................................................... 2108Doxycycline hyclate ................................................................ 2109Doxycycline monohydrate..................................................... 2111Doxylamine hydrogen succinate........................................... 2112Droperidol ............................................................................... 2113Droppers (2.1.1.)......................................................................... 15Drop point (2.2.17.).................................................................... 32Drops (nasal) and sprays (liquid nasal) ................................. 792Drops, oral ................................................................................. 791Drospirenone .......................................................................... 2115Dry extracts ............................................................................... 746Drynaria rhizome ................................................................... 1229Dry residue of extracts (2.8.16.).............................................. 276Duck plague vaccine (live)....................................................... 963Duck viral hepatitis type I vaccine (live) ............................... 964Duloxetine hydrochloride...................................................... 2116Dutasteride .............................................................................. 2118Dwarf pine oil ......................................................................... 1230Dydrogesterone....................................................................... 2120

EEar drops and ear sprays.......................................................... 782Ear powders............................................................................... 782Ear preparations........................................................................ 781Ear preparations, semi-solid ................................................... 782Ear sprays and ear drops.......................................................... 782Ear tampons .............................................................................. 782Ear washes ................................................................................. 782Ebastine.................................................................................... 2125Eclipta herb ............................................................................. 1231Econazole................................................................................. 2126Econazole nitrate .................................................................... 2127Edetate (chromium (51Cr)) injection.................................... 1049Edetate, disodium................................................................... 2082Edetate, sodium calcium........................................................ 3233Edetic acid ............................................................................... 2128Edotreotide (gallium (68Ga)) injection................................. 1062Edrophonium chloride........................................................... 2129Effervescent granules ............................................................... 786Effervescent powders ............................................................... 800Effervescent tablets................................................................... 811Efficacy of antimicrobial preservation (5.1.3.)...................... 557Efficacy of veterinary vaccines and immunosera, evaluation of(5.2.7.) ...................................................................................... 591

Egg drop syndrome ′76 vaccine (inactivated) ....................... 965Elder flower ............................................................................. 1232Electrophoresis (2.2.31.) ............................................................ 47Electrophoresis (2.2.31.) (5.8.)................................................ 677Electrophoresis, capillary (2.2.47.) ........................................... 79Electrophoresis, capillary (2.2.47.) (5.8.)............................... 677Eleutherococcus ...................................................................... 1234Emedastine difumarate .......................................................... 2129Emetine hydrochloride pentahydrate .................................. 2130Empty sterile containers of plasticised poly(vinyl chloride) forhuman blood and blood components (3.2.4.)..................... 417

Emulsifying cetostearyl alcohol (type A)............................. 1834Emulsifying cetostearyl alcohol (type B) ............................. 1835Emulsions, solutions and suspensions, oral .......................... 790Enalaprilat dihydrate.............................................................. 2133Enalapril maleate .................................................................... 2131Encephalitis vaccine (inactivated), tick-borne...................... 908Encephalomyelitis vaccine (live), infectious, avian .............. 931Endotoxins, bacterial (2.6.14.) ................................................ 194

Endotoxins, bacterial, guidelines for using the test for(5.1.10.) .................................................................................... 572

Enilconazole for veterinary use ............................................ 2134Enoxaparin sodium ................................................................ 2135Enoxolone ................................................................................ 2136Enrofloxacin for veterinary use............................................. 2137Entacapone .............................................................................. 2139Enzootic pneumonia vaccine (inactivated), porcine.......... 1001Ephedra herb ........................................................................... 1236Ephedrine, anhydrous ............................................................ 2140Ephedrine hemihydrate ......................................................... 2141Ephedrine hydrochloride....................................................... 2142Ephedrine hydrochloride, racemic ....................................... 2143Epinastine hydrochloride....................................................... 2144Epinephrine ............................................................................. 1490Epinephrine tartrate ............................................................... 1491Epirubicin hydrochloride ...................................................... 2145Eptacog alfa (activated) concentrated solution................... 2410Equine herpesvirus vaccine (inactivated).............................. 967Equine influenza vaccine (inactivated) .................................. 968Equisetum stem ...................................................................... 1237Ergocalciferol .......................................................................... 2146Ergoloid mesilates................................................................... 1944Ergometrine maleate .............................................................. 2148Ergotamine tartrate ................................................................ 2149Erysipelas vaccine (inactivated), swine................................ 1018Erythritol ................................................................................. 2150Erythromycin .......................................................................... 2151Erythromycin estolate ............................................................ 2154Erythromycin ethylsuccinate................................................. 2156Erythromycin lactobionate .................................................... 2158Erythromycin stearate ............................................................ 2160Erythropoietin concentrated solution.................................. 2162Eserine salicylate..................................................................... 3027Esketamine hydrochloride..................................................... 2166Esomeprazole magnesium trihydrate................................... 2168Essential oils .............................................................................. 743Essential oils, assay of 1,8-cineole in (2.8.11.)....................... 272Essential oils, fatty oils and resinified essential oils in(2.8.7.) ...................................................................................... 271

Essential oils, foreign esters in (2.8.6.) ................................... 271Essential oils in herbal drugs (2.8.12.) ................................... 273Essential oils, odour and taste (2.8.8.) ................................... 272Essential oils, residue on evaporation (2.8.9.)....................... 272Essential oils, solubility in alcohol (2.8.10.) .......................... 272Essential oils, water in (2.8.5.)................................................. 271Ester value (2.5.2.) .................................................................... 155Estradiol benzoate .................................................................. 2169Estradiol hemihydrate............................................................ 2171Estradiol valerate .................................................................... 2172Estriol ....................................................................................... 2173Estrogens, conjugated............................................................. 2174Etacrynic acid.......................................................................... 2177Etamsylate................................................................................ 2178Ethacridine lactate monohydrate.......................................... 2179Ethambutol hydrochloride .................................................... 2180Ethanol (96 per cent).............................................................. 2181Ethanol, anhydrous................................................................. 2183Ethanol content (2.9.10.) ......................................................... 301Ether ......................................................................................... 2185Ether, anaesthetic.................................................................... 2185Ethinylestradiol ....................................................................... 2186Ethionamide ............................................................................ 2188Ethosuximide .......................................................................... 2188Ethoxylated substances, ethylene glycol and diethylene glycolin (2.4.30.) ............................................................................... 150

Ethyl acetate ............................................................................ 2190Ethyl acrylate - methacrylic acid copolymer (1:1).............. 2727Ethyl acrylate - methacrylic acid copolymer (1:1) dispersion30 per cent ............................................................................. 2728

Ethylcellulose........................................................................... 2192Ethylcellulose (5.8.) .................................................................. 677Ethylenediamine ..................................................................... 2193



Ethylene glycol and diethylene glycol in ethoxylated substances(2.4.30.) .................................................................................... 150

Ethylene glycol monopalmitostearate .................................. 2193Ethylene glycol monostearate................................................ 2193Ethylene oxide and dioxan (2.4.25.) ....................................... 145Ethylhexanoic acid, 2- (2.4.28.)............................................... 148Ethylmorphine hydrochloride............................................... 2194Ethyl oleate .............................................................................. 2190Ethyl parahydroxybenzoate ................................................... 2191Ethyl parahydroxybenzoate sodium..................................... 3243Etidronate disodium............................................................... 2195Etilefrine hydrochloride......................................................... 2196Etodolac ................................................................................... 2197Etofenamate............................................................................. 2199Etomidate................................................................................. 2201Etoposide ................................................................................. 2202Eucalyptus leaf ........................................................................ 1238Eucalyptus oil .......................................................................... 1239Eucommia bark....................................................................... 1240Eugenol .................................................................................... 2205European goldenrod............................................................... 1265European viper venom antiserum ........................................ 1033Evaluation of efficacy of veterinary vaccines and immunosera(5.2.7.) ...................................................................................... 591

Evaluation of safety of each batch of immunosera forveterinary use (5.2.9.)............................................................. 604

Evaluation of safety of veterinary vaccines and immunosera(5.2.6.) ...................................................................................... 588

Evening primrose oil, refined................................................ 2206Excipients, functionality-related characteristics of (5.15.) .. 719Extractable volume of parenteral preparations, test for(2.9.17.) .................................................................................... 308

Extractable volume of parenteral preparations, test for (2.9.17.)(5.8.) ......................................................................................... 679

Extracts ...................................................................................... 744Extracts, dry .............................................................................. 746Extracts, dry residue of (2.8.16.)............................................. 276Extracts, liquid .......................................................................... 745Extracts, loss on drying of (2.8.17.)........................................ 276Extracts, soft .............................................................................. 746Extracts used in the preparation of herbal medicinal productsfor oral use, microbiological examination (2.6.31.) ........... 222

Extracts used in the preparation of herbal medicinal productsfor oral use, microbiological quality (5.1.8.) ....................... 571

Extracts, water for preparation of......................................... 3558Extraneous agents in viral vaccines for human use, tests for(2.6.16.) .................................................................................... 198

Extraneous agents : tests in batches of finished product ofavian live virus vaccines (2.6.25.) ......................................... 212

Extraneous agents : tests in seed lots of avian viral vaccines(2.6.24.) .................................................................................... 209

Eye drops ................................................................................... 783Eye lotions ................................................................................. 783Eye preparations ....................................................................... 782Eye preparations, semi-solid ................................................... 784

FF0 concept to steam sterilisation of aqueous preparations,application of (5.1.5.) ............................................................. 560

Factor II, human coagulation, assay of (2.7.18.)................... 254Factor IX, human coagulation .............................................. 2416Factor IX, human coagulation, assay of (2.7.11.) ................. 248Factor VIIa (rDNA) concentrated solution, human coagulation................................................................................................ 2410

Factor VII, human coagulation............................................. 2408Factor VII, human coagulation, assay of (2.7.10.)................ 247Factor VIII, human coagulation ........................................... 2414Factor VIII, human coagulation, assay of (2.7.4.) ................ 236Factor VIII (rDNA), human coagulation ............................ 2415Factor X, human coagulation, assay of (2.7.19.) ................... 255Factor XI, human coagulation .............................................. 2417Factor XI, human coagulation, assay of (2.7.22.) ................. 258

Falling ball viscometer method (2.2.49.) ................................. 85Famotidine............................................................................... 2211Fat, hard ................................................................................... 2386Fatty acids, composition by gas chromatography (2.4.22.).. 136Fatty acids in oils rich in omega-3 acids, composition of(2.4.29.) .................................................................................... 148

Fatty oils, alkaline impurities in (2.4.19.) .............................. 133Fatty oils and herbal drugs, heavy metals in (2.4.27.).......... 147Fatty oils and resinified essential oils in essential oils(2.8.7.) ...................................................................................... 271

Fatty oils, foreign oils in, by thin-layer chromatography(2.4.21.) .................................................................................... 136

Fatty oils, identification by thin-layer chromatography(2.3.2.) ...................................................................................... 122

Fatty oils, sterols in (2.4.23.).................................................... 139Fatty oils, vegetable................................................................... 775Fc function of immunoglobulin, test for (2.7.9.) .................. 246Febantel for veterinary use .................................................... 2212Feeding stuffs for veterinary use, medicated, premixes for.. 800Felbinac .................................................................................... 2213Feline calicivirosis vaccine (inactivated)................................ 970Feline calicivirosis vaccine (live)............................................. 971Feline chlamydiosis vaccine (inactivated) ............................. 972Feline infectious enteritis (feline panleucopenia) vaccine(inactivated) ............................................................................ 973

Feline infectious enteritis (feline panleucopenia) vaccine(live) ......................................................................................... 974

Feline leukaemia vaccine (inactivated) .................................. 975Feline panleucopenia vaccine (inactivated)........................... 973Feline panleucopenia vaccine (live) ....................................... 974Feline viral rhinotracheitis vaccine (inactivated) ................. 976Feline viral rhinotracheitis vaccine (live) .............................. 977Felodipine ................................................................................ 2214Felypressin ............................................................................... 2215Fenbendazole for veterinary use........................................... 2217Fenbufen .................................................................................. 2218Fennel, bitter ........................................................................... 1241Fennel, sweet ........................................................................... 1242Fenofibrate............................................................................... 2219Fenoterol hydrobromide ........................................................ 2220Fentanyl.................................................................................... 2221Fentanyl citrate........................................................................ 2223Fenticonazole nitrate .............................................................. 2224Fenugreek ................................................................................ 1244Fermentation, products of ....................................................... 758Ferric chloride hexahydrate................................................... 2225Ferrous fumarate..................................................................... 2226Ferrous gluconate ................................................................... 2227Ferrous sulfate, dried.............................................................. 2228Ferrous sulfate heptahydrate ................................................. 2229Feverfew................................................................................... 1244Fexofenadine hydrochloride.................................................. 2230Fibrinogen, human................................................................. 2418Fibrin sealant kit ..................................................................... 2231Filgrastim concentrated solution.......................................... 2233Films, orodispersible ................................................................ 796Finasteride ............................................................................... 2235Fineness, powder (2.9.35.) ....................................................... 346Fish oil, rich in omega-3 acids .............................................. 2236Flavoxate hydrochloride......................................................... 2238Flecainide acetate.................................................................... 2239Fleeceflower root..................................................................... 1245Flocculation value (Lf) of diphtheria and tetanus toxins andtoxoids (Ramon assay) (2.7.27.)............................................ 261

Flowability (2.9.16.) .................................................................. 307Flow cytometry (2.7.24.).......................................................... 259FLT (18F) injection .................................................................. 1045Flubendazole ........................................................................... 2241Flucloxacillin magnesium octahydrate ................................ 2242Flucloxacillin sodium............................................................. 2243Fluconazole.............................................................................. 2245Flucytosine............................................................................... 2246Fludarabine phosphate........................................................... 2248



Fludeoxyglucose (18F) injection ............................................ 1052Fludrocortisone acetate.......................................................... 2250Flumazenil ............................................................................... 2251Flumazenil (N-[11C]methyl) injection.................................. 1054Flumequine.............................................................................. 2253Flumetasone pivalate.............................................................. 2254Flunarizine dihydrochloride.................................................. 2255Flunitrazepam ......................................................................... 2256Flunixin meglumine for veterinary use ............................... 2257Fluocinolone acetonide.......................................................... 2258Fluocortolone pivalate............................................................ 2259Fluorescein .............................................................................. 2260Fluorescein sodium ................................................................ 2262Fluoride (18F) solution for radiolabelling............................. 1055Fluorides (2.4.5.) ....................................................................... 128Fluorimetry (2.2.21.) .................................................................. 35Fluorodeoxythymidine (18F) injection ................................. 1045Fluorodopa (18F) (prepared by electrophilic substitution)injection ................................................................................. 1056

Fluoromisonidazole (18F) injection....................................... 1058Fluorouracil ............................................................................. 2263Fluoxetine hydrochloride....................................................... 2264Flupentixol dihydrochloride.................................................. 2266Fluphenazine decanoate......................................................... 2268Fluphenazine dihydrochloride .............................................. 2269Fluphenazine enantate ........................................................... 2271Flurazepam monohydrochloride .......................................... 2272Flurbiprofen............................................................................. 2273Fluspirilene .............................................................................. 2274Flutamide................................................................................. 2275Fluticasone propionate........................................................... 2276Flutrimazole ............................................................................ 2278Fluvastatin sodium ................................................................. 2279Fluvoxamine maleate.............................................................. 2281FMISO (18F) injection ............................................................ 1058Foams, cutaneous ..................................................................... 790Foams, intrauterine .................................................................. 787Foams, medicated ..................................................................... 784Foams, rectal ............................................................................. 807Foams, vaginal........................................................................... 813Folic acid.................................................................................. 2283Folinate, calcium..................................................................... 1734Follitropin................................................................................ 2284Follitropin concentrated solution ......................................... 2290Foot-and-mouth disease (ruminants) vaccine(inactivated) ............................................................................ 978

Foreign esters in essential oils (2.8.6.).................................... 271Foreign matter (2.8.2.) ............................................................. 271Foreign oils in fatty oils by thin-layer chromatography(2.4.21.) .................................................................................... 136

Formaldehyde, free (2.4.18.).................................................... 132Formaldehyde solution (35 per cent) ................................... 2295Formoterol fumarate dihydrate............................................. 2296Foscarnet sodium hexahydrate ............................................. 2297Fosfomycin calcium................................................................ 2299Fosfomycin sodium ................................................................ 2300Fosfomycin trometamol......................................................... 2301Fosinopril sodium .................................................................. 2302Fourstamen stephania root.................................................... 1246Fowl cholera vaccine (inactivated) ......................................... 980Fowl-pox vaccine (live) ............................................................ 981Framycetin sulfate .................................................................. 2305Frangula bark .......................................................................... 1247Frangula bark dry extract, standardised.............................. 1249Frankincense, Indian.............................................................. 1276Fraxinus rhynchophylla bark ................................................ 1249Free formaldehyde (2.4.18.)..................................................... 132Freezing point (2.2.18.) .............................................................. 34Fresh bilberry fruit dry extract, refined and standardised.. 1250Friability of granules and spheroids (2.9.41.)........................ 359Friability of uncoated tablets (2.9.7.) ..................................... 298Friability of uncoated tablets (2.9.7.) (5.8.) ........................... 678Fructose.................................................................................... 2306

Fucus ........................................................................................ 1286Fulvestrant ............................................................................... 2307Fumitory .................................................................................. 1252Functional groups and ions, identification reactions of(2.3.1.) ...................................................................................... 119

Functionality-related characteristics of excipients (5.15.) ... 719Furosemide .............................................................................. 2309Furunculosis vaccine (inactivated, oil-adjuvanted, injectable)for salmonids........................................................................... 982

Fusidate, sodium..................................................................... 3245Fusidic acid.............................................................................. 2310

GGabapentin .............................................................................. 2317Galactose.................................................................................. 2318Galantamine hydrobromide .................................................. 2319Gallium (67Ga) citrate injection ............................................ 1060Gallium (68Ga) chloride solution for radiolabelling ........... 1060Gallium (68Ga) DOTATOC injection ................................... 1062Gallium (68Ga) edotreotide injection ................................... 1062Ganciclovir .............................................................................. 2321Gargles ....................................................................................... 794Garlic for homoeopathic preparations................................. 1447Garlic powder.......................................................................... 1254Gas adsorption, specific surface area by (2.9.26.)................. 329Gas adsorption, specific surface area by (2.9.26.) (5.8.) ...... 679Gas chromatography (2.2.28.) ................................................... 43Gas detector tubes (2.1.6.) ......................................................... 17Gases, carbon dioxide in (2.5.24.) .......................................... 161Gases, carbon monoxide in (2.5.25.)...................................... 162Gases, nitrogen monoxide and nitrogen dioxide in(2.5.26.) .................................................................................... 163

Gases, nitrous oxide in (2.5.35.) ............................................. 168Gases, oxygen in (2.5.27.) ........................................................ 163Gases, water in (2.5.28.) ........................................................... 163Gas-gangrene antitoxin, mixed............................................. 1030Gas-gangrene antitoxin (novyi) ............................................ 1030Gas-gangrene antitoxin (perfringens).................................. 1031Gas-gangrene antitoxin (septicum)...................................... 1032Gas pycnometric density of solids (2.9.23.)........................... 324Gastro-resistant capsules ......................................................... 780Gastro-resistant granules ......................................................... 786Gastro-resistant tablets ............................................................ 811Gelatin...................................................................................... 2323Gels ............................................................................................. 808Gels for injections..................................................................... 798Gemcitabine hydrochloride................................................... 2324Gemfibrozil.............................................................................. 2325General notices (1.) ...................................................................... 3General texts on biological products (5.2.) ........................... 579General texts on microbiology (5.1.) ..................................... 555Gene transfer medicinal products for human use (5.14.).... 705Gentamicin sulfate.................................................................. 2326Gentian root ............................................................................ 1254Gentian tincture...................................................................... 1255Gestodene ................................................................................ 2328Ginger ...................................................................................... 1256Gingival solutions ..................................................................... 794Ginkgo dry extract, refined and quantified......................... 1257Ginkgo leaf .............................................................................. 1259Ginseng .................................................................................... 1261Ginseng dry extract ................................................................ 1262Glass containers for pharmaceutical use (3.2.1.) .................. 409Glibenclamide ......................................................................... 2330Gliclazide ................................................................................. 2332Glimepiride ............................................................................. 2333Glipizide................................................................................... 2335Glossary (dosage forms) .......................................................... 779Glucagon, human ................................................................... 2337Glucoheptonate, calcium ....................................................... 1736Glucosamine hydrochloride .................................................. 2338Glucosamine sulfate sodium chloride.................................. 2339



Glucose, anhydrous ................................................................ 2340Glucose, liquid ........................................................................ 2341Glucose, liquid, spray-dried .................................................. 2342Glucose monohydrate ............................................................ 2343Glutamic acid .......................................................................... 2344Glutathione.............................................................................. 2345Glycan analysis of glycoproteins (2.2.59.) ............................. 100Glycerol .................................................................................... 2346Glycerol (85 per cent) ............................................................ 2348Glycerol dibehenate................................................................ 2349Glycerol distearate .................................................................. 2350Glycerol formal ....................................................................... 2351Glycerol monocaprylate......................................................... 2351Glycerol monocaprylocaprate ............................................... 2352Glycerol monolinoleate.......................................................... 2353Glycerol mono-oleate ............................................................. 2354Glycerol monostearate 40-55 ................................................ 2355Glycerol triacetate................................................................... 3459Glyceryl trinitrate solution .................................................... 2356Glycine ..................................................................................... 2357Glycoproteins, glycan analysis of (2.2.59.) ............................ 100Glycopyrronium bromide...................................................... 2358Glycyrrhizate ammonium...................................................... 1552Goldenrod................................................................................ 1264Goldenrod, European............................................................. 1265Goldenseal rhizome................................................................ 1266Gonadorelin acetate................................................................ 2360Gonadotrophin, chorionic..................................................... 2361Gonadotrophin, equine serum, for veterinary use............. 2362Goserelin.................................................................................. 2363Grafted copolymer, macrogol poly(vinyl alcohol) ............. 2660Gramicidin .............................................................................. 2365Granisetron hydrochloride.................................................... 2366Granules..................................................................................... 785Granules and powders for oral solutions and suspensions.. 791Granules and powders for syrups ........................................... 791Granules and spheroids, friability of (2.9.41.)....................... 359Granules, coated ....................................................................... 786Granules, effervescent .............................................................. 786Granules, gastro-resistant ........................................................ 786Granules, modified-release...................................................... 786Greater celandine.................................................................... 1268Griseofulvin............................................................................. 2367Guaiacol ................................................................................... 2368Guaifenesin.............................................................................. 2370Guanethidine monosulfate .................................................... 2371Guar.......................................................................................... 1269Guar galactomannan .............................................................. 2371Guidelines for using the test for bacterial endotoxins(5.1.10.) .................................................................................... 572

Guidelines for using the test for sterility (5.1.9.) .................. 572

HHaemagglutinins, anti-A and anti-B (2.6.20.)....................... 203Haematopoietic products, numeration of CD34/CD45+ cellsin (2.7.23.) ............................................................................... 258

Haematopoietic progenitor cells, human, colony-forming cellassay for (2.7.28.) .................................................................... 262

Haematopoietic stem cells, human....................................... 2419Haemodiafiltration and haemofiltration, solutions for...... 2378Haemodialysis, concentrated solutions for ......................... 2376Haemodialysis solutions, concentrated, water fordiluting................................................................................... 2375

Haemodialysis, solutions for ................................................. 2376Haemofiltration and haemodiafiltration, solutions for...... 2378Haemophilus type b (conjugate), diphtheria, tetanus andpertussis (acellular, component) vaccine (adsorbed)......... 830

Haemophilus type b (conjugate), diphtheria, tetanus, pertussis(acellular, component) and poliomyelitis (inactivated)vaccine (adsorbed) ................................................................. 840

Haemophilus type b (conjugate), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and poliomyelitis(inactivated) vaccine (adsorbed) .......................................... 837

Haemophilus type b (conjugate), diphtheria, tetanus,pertussis (whole cell) and poliomyelitis (inactivated) vaccine(adsorbed) ............................................................................... 844

Haemophilus type b conjugate vaccine.................................. 848Haemorrhagic disease vaccine (inactivated), rabbit........... 1007Halofantrine hydrochloride................................................... 2381Haloperidol.............................................................................. 2382Haloperidol decanoate ........................................................... 2383Halothane ................................................................................ 2385Hamamelis leaf........................................................................ 1270Hard capsules ............................................................................ 780Hard fat .................................................................................... 2386Hard paraffin........................................................................... 2964Harmonisation, pharmacopoeial (5.8.).................................. 677Hawthorn berries.................................................................... 1271Hawthorn leaf and flower ...................................................... 1272Hawthorn leaf and flower dry extract .................................. 1273Hawthorn leaf and flower liquid extract, quantified .......... 1274Heavy bismuth subnitrate...................................................... 1676Heavy kaolin............................................................................ 2565Heavy magnesium carbonate ................................................ 2670Heavy magnesium oxide........................................................ 2677Heavy metals (2.4.8.) ................................................................ 128Heavy metals in herbal drugs and fatty oils (2.4.27.)........... 147Hedera helix for homoeopathic preparations ..................... 1448Helium ..................................................................................... 2387Heparin, assay of (2.7.5.) ......................................................... 237Heparin calcium ..................................................................... 2388Heparin in coagulation factors, assay of (2.7.12.)................. 249Heparins, low-molecular-mass ............................................. 2392Heparin sodium...................................................................... 2390Hepatitis A immunoglobulin, human.................................. 2420Hepatitis A (inactivated, adsorbed) and typhoid polysaccharidevaccine ..................................................................................... 851

Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine(adsorbed) ............................................................................... 852

Hepatitis A vaccine, assay of (2.7.14.) .................................... 251Hepatitis A vaccine (inactivated, adsorbed).......................... 853Hepatitis A vaccine (inactivated, virosome) ......................... 854Hepatitis B immunoglobulin for intravenous administration,human .................................................................................... 2421

Hepatitis B immunoglobulin, human .................................. 2420Hepatitis B (rDNA), diphtheria and tetanus vaccine(adsorbed) ............................................................................... 825

Hepatitis B (rDNA), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ......................... 832

Hepatitis B (rDNA), diphtheria, tetanus, pertussis (acellular,component), poliomyelitis (inactivated) and haemophilustype b conjugate vaccine (adsorbed) .................................... 837

Hepatitis B vaccine (rDNA) .................................................... 857Hepatitis B vaccine (rDNA), assay of (2.7.15.)...................... 252Hepatitis C virus (HCV), validation of nucleic acidamplification techniques for the detection of HCV RNA inplasma pools : guidelines ....................................................... 204

Hepatitis type I vaccine (live), viral, duck ............................. 964Heptaminol hydrochloride .................................................... 2394Herbal drug preparations ........................................................ 746Herbal drugs.............................................................................. 746Herbal drugs and fatty oils, heavy metals in (2.4.27.).......... 147Herbal drugs, determination of aflatoxin B1 in (2.8.18.) ..... 276Herbal drugs, essential oils in (2.8.12.).................................. 273Herbal drugs for homoeopathic preparations..................... 1429Herbal drugs, microscopic examination of (2.8.23)............. 282Herbal drugs : sampling and sample preparation (2.8.20.).. 278Herbal drugs, tannins in (2.8.14.)........................................... 275Herbal drugs, test for aristolochic acids in (2.8.21) ............. 279Herbal medicinal products for oral use and extracts used intheir preparation, microbiological examination (2.6.31.).. 222

Herbal medicinal products for oral use and extracts used intheir preparation, microbiological quality (5.1.8.) ............. 571



Herbal preparations.................................................................. 746Herbal substances ..................................................................... 746Herbal teas................................................................................. 747Herbal teas, instant................................................................... 748Herpesvirus vaccine (inactivated), equine............................. 967Herpes zoster (shingles) vaccine (live)................................... 902Hexamidine diisetionate ........................................................ 2395Hexetidine ............................................................................... 2396Hexosamines in polysaccharide vaccines (2.5.20.) ............... 160Hexylresorcinol ....................................................................... 2397Highly purified water ............................................................. 3559Histamine (2.6.10.) ................................................................... 184Histamine dihydrochloride ................................................... 2398Histidine .................................................................................. 2399Histidine hydrochloride monohydrate ................................ 2400Homatropine hydrobromide ................................................. 2401Homatropine methylbromide ............................................... 2402Homeopathic preparations, hydrastis canadensis for ........ 1449Homoeopathic pillules, impregnated ................................... 1441Homoeopathic preparations.................................................. 1430Homoeopathic preparations, anamirta cocculus for.......... 1442Homoeopathic preparations, arsenious trioxide for .......... 1443Homoeopathic preparations, calcium iodide tetrahydratefor ........................................................................................... 1444

Homoeopathic preparations, common stinging nettlefor ........................................................................................... 1445

Homoeopathic preparations, copper acetate monohydratefor ........................................................................................... 1446

Homoeopathic preparations, copper for ............................. 1446Homoeopathic preparations, garlic for ................................ 1447Homoeopathic preparations, hedera helix for .................... 1448Homoeopathic preparations, herbal drugs for.................... 1429Homoeopathic preparations, honey bee for........................ 1449Homoeopathic preparations, hyoscyamus for .................... 1450Homoeopathic preparations, hypericum for....................... 1451Homoeopathic preparations, iron for .................................. 1452Homoeopathic preparations, mother tinctures for ............ 1440Homoeopathic preparations, oriental cashew for .............. 1453Homoeopathic preparations, pillules for ............................. 1441Homoeopathic preparations, potassium dichromate for... 1454Homoeopathic preparations, saffron for ............................. 1455Homoeopathic preparations, sodium tetrachloroauratedihydrate for.......................................................................... 1455

Homoeopathic preparations, sulfur for ............................... 1456Homoeopathic stocks (methods of preparation of) andpotentisation ......................................................................... 1431

Honey ....................................................................................... 2403Honey bee for homoeopathic preparations......................... 1449Hop strobile............................................................................. 1274Human α-1-proteinase inhibitor .......................................... 2428Human α-1-proteinase inhibitor, assay of (2.7.32.).............. 266Human albumin injection, iodinated (125I) ......................... 1064Human albumin solution ...................................................... 2404Human anti-D immunoglobulin .......................................... 2406Human anti-D immunoglobulin, assay of (2.7.13.) ............. 249Human anti-D immunoglobulin for intravenousadministration....................................................................... 2407

Human antithrombin III, assay of (2.7.17.)........................... 254Human antithrombin III concentrate .................................. 2407Human coagulation factor II, assay of (2.7.18.).................... 254Human coagulation factor IX ............................................... 2416Human coagulation factor IX, assay of (2.7.11.) .................. 248Human coagulation factor VII.............................................. 2408Human coagulation factor VIIa (rDNA) concentratedsolution .................................................................................. 2410

Human coagulation factor VII, assay of (2.7.10.)................. 247Human coagulation factor VIII ............................................ 2414Human coagulation factor VIII, assay of (2.7.4.) ................. 236Human coagulation factor VIII (rDNA) ............................. 2415Human coagulation factor X, assay of (2.7.19.) .................... 255Human coagulation factor XI ............................................... 2417Human coagulation factor XI, assay of (2.7.22.) .................. 258Human fibrinogen .................................................................. 2418

Human glucagon..................................................................... 2337Human haematopoietic progenitor cells, colony-forming cellassay for (2.7.28.) .................................................................... 262

Human haematopoietic stem cells........................................ 2419Human hepatitis A immunoglobulin................................... 2420Human hepatitis B immunoglobulin ................................... 2420Human hepatitis B immunoglobulin for intravenousadministration....................................................................... 2421

Human insulin ........................................................................ 2491Human measles immunoglobulin ........................................ 2421Human normal immunoglobulin ......................................... 2421Human normal immunoglobulin for intravenousadministration....................................................................... 2423

Human papillomavirus vaccine (rDNA) ............................... 859Human plasma for fractionation .......................................... 2425Human plasma (pooled and treated for virusinactivation) .......................................................................... 2426

Human plasmin inhibitor, assay of (2.7.25.) ......................... 261Human protein C, assay of (2.7.30.)....................................... 265Human protein S, assay of (2.7.31.)........................................ 266Human prothrombin complex .............................................. 2429Human rabies immunoglobulin ........................................... 2431Human rubella immunoglobulin ......................................... 2432Human tetanus immunoglobulin ......................................... 2432Human varicella immunoglobulin ....................................... 2434Human varicella immunoglobulin for intravenousadministration....................................................................... 2434

Human von Willebrand factor .............................................. 2435Human von Willebrand factor, assay of (2.7.21.) ................. 257Hyaluronate, sodium.............................................................. 3248Hyaluronidase ........................................................................ 2436Hydralazine hydrochloride.................................................... 2437Hydrastis canadensis for homoeopathic preparations ....... 1449Hydrochloric acid, concentrated .......................................... 2438Hydrochloric acid, dilute ....................................................... 2438Hydrochlorothiazide .............................................................. 2439Hydrocodone hydrogen tartrate 2.5-hydrate ...................... 2440Hydrocortisone ....................................................................... 2442Hydrocortisone acetate .......................................................... 2444Hydrocortisone hydrogen succinate..................................... 2446Hydrogenated arachis oil ....................................................... 1584Hydrogenated castor oil ......................................................... 1782Hydrogenated cottonseed oil................................................. 1968Hydrogenated soya-bean oil.................................................. 3289Hydrogenated vegetable oils, nickel in (2.4.31.) ................... 150Hydrogenated wool fat........................................................... 3569Hydrogen peroxide solution (30 per cent) .......................... 2448Hydrogen peroxide solution (3 per cent) ............................ 2448Hydromorphone hydrochloride............................................ 2449Hydrophobic colloidal silica.................................................. 3220Hydrous wool fat .................................................................... 3570Hydroxocobalamin acetate .................................................... 2450Hydroxocobalamin chloride.................................................. 2451Hydroxocobalamin sulfate..................................................... 2452Hydroxycarbamide ................................................................. 2453Hydroxyethylcellulose ............................................................ 2455Hydroxyethylmethylcellulose ................................................ 2745Hydroxyethyl salicylate .......................................................... 2454Hydroxyethyl starches ............................................................ 3307Hydroxyl value (2.5.3.)............................................................. 155Hydroxypropylbetadex........................................................... 2456Hydroxypropylcellulose ......................................................... 2458Hydroxypropylmethylcellulose ............................................. 2466Hydroxypropylmethylcellulose phthalate ............................ 2468Hydroxypropyl starch............................................................. 3303Hydroxypropyl starch, pregelatinised .................................. 3305Hydroxyzine hydrochloride................................................... 2459Hymecromone......................................................................... 2460Hyoscine .................................................................................. 2461Hyoscine butylbromide.......................................................... 2462Hyoscine hydrobromide ........................................................ 2464Hyoscyamine sulfate............................................................... 2465Hyoscyamus for homoeopathic preparations ..................... 1450



Hypericum............................................................................... 1391Hypericum for homoeopathic preparations........................ 1451Hypromellose .......................................................................... 2466Hypromellose (5.8.) .................................................................. 677Hypromellose phthalate ......................................................... 2468Hyproxypropylmethylcellulose (5.8.) ..................................... 677

IIbuprofen ................................................................................. 2473Iceland moss............................................................................ 1275ICH (5.8.)................................................................................... 677Ichthammol ............................................................................. 2475Identification (2.3.) ................................................................... 119Identification and control of residual solvents (2.4.24.) ...... 141Identification of fatty oils by thin-layer chromatography(2.3.2.) ...................................................................................... 122

Identification of phenothiazines by thin-layer chromatography(2.3.3.) ...................................................................................... 123

Identification reactions of ions and functional groups(2.3.1.) ...................................................................................... 119

Idoxuridine .............................................................................. 2476Ifosfamide ................................................................................ 2476Imipenem monohydrate ........................................................ 2478Imipramine hydrochloride .................................................... 2479Immunochemical methods (2.7.1.) ........................................ 229Immunoglobulin for human use, anti-T lymphocyte,animal .................................................................................... 1575

Immunoglobulin for intravenous administration, humananti-D ..................................................................................... 2407

Immunoglobulin for intravenous administration, humanhepatitis B.............................................................................. 2421

Immunoglobulin for intravenous administration, humannormal.................................................................................... 2423

Immunoglobulin for intravenous administration, humanvaricella .................................................................................. 2434

Immunoglobulin, human anti-D.......................................... 2406Immunoglobulin, human anti-D, assay of (2.7.13.) ............. 249Immunoglobulin, human hepatitis A .................................. 2420Immunoglobulin, human hepatitis B................................... 2420Immunoglobulin, human measles ........................................ 2421Immunoglobulin, human normal......................................... 2421Immunoglobulin, human rabies ........................................... 2431Immunoglobulin, human rubella ......................................... 2432Immunoglobulin, human tetanus......................................... 2432Immunoglobulin, human varicella ....................................... 2434Immunoglobulin, test for anticomplementary activity of(2.6.17.) .................................................................................... 200

Immunoglobulin, test for Fc function of (2.7.9.).................. 246Immunological veterinary medicinal products, substances ofanimal origin for the production of (5.2.5.)........................ 587

Immunosera and vaccines, phenol in (2.5.15.) ..................... 159Immunosera and vaccines, veterinary, evaluation of efficacyof (5.2.7.).................................................................................. 591

Immunosera and vaccines, veterinary, evaluation of safety(5.2.6.) ...................................................................................... 588

Immunosera for human use, animal ...................................... 748Immunosera for veterinary use............................................... 750Immunosera for veterinary use, evaluation of the safety ofeach batch (5.2.9.)................................................................... 604

Implants ..................................................................................... 798Impurities in substances for pharmaceutical use, control of(5.10.) ....................................................................................... 689

Indapamide.............................................................................. 2480Indian frankincense................................................................ 1276Indicators, relationship between approximate pH and colour(2.2.4.) ........................................................................................ 25

Indinavir sulfate ...................................................................... 2482Indium (111In) chloride solution ........................................... 1065Indium (111In) oxine solution ................................................ 1066Indium (111In) pentetate injection ........................................ 1066Indometacin ............................................................................ 2484

Inductively coupled plasma-atomic emission spectrometry(2.2.57.) ...................................................................................... 97

Inductively coupled plasma-mass spectrometry (2.2.58.) ..... 98Infectious bovine rhinotracheitis vaccine (live).................... 983Infectious bronchitis vaccine (inactivated), avian ................ 925Infectious bronchitis vaccine (live), avian ............................. 926Infectious bursal disease vaccine (inactivated), avian.......... 928Infectious bursal disease vaccine (live), avian....................... 929Infectious chicken anaemia vaccine (live) ............................. 984Infectious encephalomyelitis vaccine (live), avian................ 931Infectious enteritis vaccine (inactivated), feline ................... 973Infectious enteritis vaccine (live), feline ................................ 974Infectious laryngotracheitis vaccine (live), avian ................. 932Infectious rhinotracheitis vaccine (live), turkey ................. 1022Influenza vaccine (inactivated), equine ................................. 968Influenza vaccine (inactivated), porcine.............................. 1003Influenza vaccine (split virion, inactivated) .......................... 861Influenza vaccine (surface antigen, inactivated)................... 863Influenza vaccine (surface antigen, inactivated, prepared incell cultures) ............................................................................ 865

Influenza vaccine (surface antigen, inactivated, virosome).. 867Influenza vaccine (whole virion, inactivated) ....................... 868Influenza vaccine (whole virion, inactivated, prepared in cellcultures) ................................................................................... 870

Infrared absorption spectrophotometry (2.2.24.)................... 38Infusions .................................................................................... 797Inhalation gas, krypton (81mKr)............................................. 1071Inhalation powders................................................................... 803Inhalation, preparations for .................................................... 800Inhalation, preparations for : aerodynamic assessment of fineparticles (2.9.18.) .................................................................... 309

Injectable insulin preparations.............................................. 2499Injections ................................................................................... 797Injections, gels for..................................................................... 798Injections or infusions, concentrates for ............................... 797Injections or infusions, powders for....................................... 797Inositol, myo- .......................................................................... 2810Inserts, ophthalmic................................................................... 784Instant herbal teas .................................................................... 748Insulin aspart........................................................................... 2485Insulin, bovine ........................................................................ 2486Insulin glargine ....................................................................... 2489Insulin, human........................................................................ 2491Insulin injection, biphasic ..................................................... 2493Insulin injection, biphasic isophane..................................... 2493Insulin injection, isophane .................................................... 2494Insulin injection, soluble ....................................................... 2494Insulin lispro ........................................................................... 2494Insulin, porcine ....................................................................... 2497Insulin preparations, injectable............................................. 2499Insulin zinc injectable suspension ........................................ 2501Insulin zinc injectable suspension (amorphous) ................ 2502Insulin zinc injectable suspension (crystalline) .................. 2502Interferon alfa-2 concentrated solution ............................... 2502Interferon beta-1a concentrated solution ............................ 2505Interferon gamma-1b concentrated solution ...................... 2507Interferons, assay of (5.6.)........................................................ 663International System (SI) units (1.) ............................................ 3Intramammary preparations for veterinary use ................... 786Intraruminal devices ................................................................ 787Intrauterine capsules ................................................................ 787Intrauterine foams .................................................................... 787Intrauterine preparations for veterinary use ......................... 787Intrauterine solutions, suspensions ........................................ 787Intrauterine sticks ..................................................................... 787Intrauterine tablets ................................................................... 787Intrinsic dissolution (2.9.29.) .................................................. 331In vivo assay of poliomyelitis vaccine (inactivated)(2.7.20.) .................................................................................... 255

Iobenguane (123I) injection .................................................... 1067Iobenguane (131I) injection for diagnostic use..................... 1068Iobenguane (131I) injection for therapeutic use................... 1069



Iobenguane sulfate for radiopharmaceutical prepara-tions........................................................................................ 1070

Iodinated (125I) human albumin injection ........................... 1064Iodinated povidone ................................................................ 3081Iodine ....................................................................................... 2511Iodine value (2.5.4.).................................................................. 155Iodixanol .................................................................................. 2511Iodohippurate (sodium) dihydrate for radiopharmaceuticalpreparations .......................................................................... 1085

Iodomethylnorcholesterol (131I) injection............................ 1070Iohexol...................................................................................... 2514Ionic concentration, potentiometric determination of usingion-selective electrodes (2.2.36.)............................................. 58

Ions and functional groups, identification reactions of(2.3.1.) ...................................................................................... 119

Ion-selective electrodes, potentiometric determination ofionic concentration (2.2.36.) ................................................... 58

Iopamidol................................................................................. 2518Iopanoic acid ........................................................................... 2519Iopromide ................................................................................ 2520Iotrolan .................................................................................... 2523Ioxaglic acid............................................................................. 2525Ipecacuanha liquid extract, standardised ............................ 1277Ipecacuanha, prepared ........................................................... 1278Ipecacuanha root .................................................................... 1278Ipecacuanha tincture, standardised...................................... 1279Ipratropium bromide ............................................................. 2527Irbesartan................................................................................. 2528Iron (2.4.9.)................................................................................ 131Iron for homoeopathic preparations.................................... 1452Irrigation, preparations for...................................................... 805Isatis root ................................................................................. 1280Isoconazole .............................................................................. 2530Isoconazole nitrate.................................................................. 2531Isoelectric focusing (2.2.54.) ..................................................... 85Isoelectric focusing (2.2.54.) (5.8.) ......................................... 677Isoflurane ................................................................................. 2532Isoleucine................................................................................. 2533Isomalt ..................................................................................... 2534Isoniazid................................................................................... 2536Isophane insulin injection ..................................................... 2494Isoprenaline hydrochloride ................................................... 2536Isoprenaline sulfate................................................................. 2537Isopropyl alcohol .................................................................... 2538Isopropyl myristate................................................................. 2539Isopropyl palmitate................................................................. 2540Isosorbide dinitrate, diluted ................................................. 2540Isosorbide mononitrate, diluted .......................................... 2542Isotretinoin .............................................................................. 2543Isoxsuprine hydrochloride..................................................... 2545Ispaghula husk ........................................................................ 1281Ispaghula seed ......................................................................... 1282Isradipine ................................................................................. 2547Itraconazole ............................................................................. 2548Ivermectin................................................................................ 2549Ivy leaf ...................................................................................... 1282

JJavanese turmeric.................................................................... 1409Java tea ..................................................................................... 1284Josamycin................................................................................. 2555Josamycin propionate............................................................. 2557Juniper...................................................................................... 1285Juniper oil ................................................................................ 1285

KKanamycin acid sulfate .......................................................... 2563Kanamycin monosulfate ........................................................ 2564Kaolin, heavy........................................................................... 2565Kelp........................................................................................... 1286Ketamine hydrochloride ........................................................ 2565Ketobemidone hydrochloride ............................................... 2566

Ketoconazole ........................................................................... 2567Ketoprofen ............................................................................... 2569Ketorolac trometamol ............................................................ 2571Ketotifen hydrogen fumarate ................................................ 2572Knotgrass ................................................................................. 1287Krypton (81mKr) inhalation gas ............................................. 1071Kudzuvine root ....................................................................... 1288Kudzuvine root, Thomson..................................................... 1402

LLabetalol hydrochloride......................................................... 2577Lactic acid................................................................................ 2578Lactic acid, (S)- ....................................................................... 2579Lactitol monohydrate ............................................................. 2580Lactobionic acid...................................................................... 2581Lactose, anhydrous ................................................................. 2582Lactose monohydrate ............................................................. 2584Lactulose .................................................................................. 2585Lactulose, liquid...................................................................... 2587Lamivudine.............................................................................. 2589Lamotrigine ............................................................................. 2591Lansoprazole ........................................................................... 2592Largehead atractylodes rhizome ........................................... 1160Laryngotracheitis vaccine (live), infectious, avian ............... 932Laser light diffraction, particle size analysis by (2.9.31.) .... 333Laurilsulfate, sodium.............................................................. 3254Lauromacrogol 400................................................................. 2594Lauroyl macrogolglycerides................................................... 2596Lavender flower ...................................................................... 1289Lavender oil ............................................................................. 1291Lavender oil, spike.................................................................. 1390Lead in sugars (2.4.10.) ............................................................ 131Leflunomide ............................................................................ 2597Lemon oil................................................................................. 1292Lemon verbena leaf ................................................................ 1293Leptospirosis vaccine (inactivated), bovine........................... 937Leptospirosis vaccine (inactivated), canine ........................... 948Letrozole .................................................................................. 2598Leucine..................................................................................... 2599Leukaemia vaccine (inactivated), feline................................. 975Leuprorelin .............................................................................. 2601Levamisole for veterinary use ............................................... 2602Levamisole hydrochloride ..................................................... 2603Levetiracetam.......................................................................... 2604Levocabastine hydrochloride ................................................ 2606Levocarnitine........................................................................... 2607Levodopa ................................................................................. 2608Levodropropizine.................................................................... 2610Levofolinate pentahydrate, calcium...................................... 1745Levomenthol............................................................................ 2611Levomepromazine hydrochloride......................................... 2612Levomepromazine maleate.................................................... 2613Levomethadone hydrochloride ............................................. 2614Levonorgestrel......................................................................... 2615Levothyroxine sodium ........................................................... 2618Levulinate dihydrate, calcium ............................................... 1748Lidocaine ................................................................................. 2620Lidocaine hydrochloride........................................................ 2621Light liquid paraffin ............................................................... 2965Light magnesium carbonate .................................................. 2671Light magnesium oxide.......................................................... 2677Lime flower.............................................................................. 1295Limit tests (2.4.) ........................................................................ 127Limit tests, standard solutions for (4.1.2.) ............................. 536Lincomycin hydrochloride .................................................... 2622Linen thread, sterile, in distributor for veterinary use ..... 1128Linoleoyl macrogolglycerides................................................ 2624Linseed ..................................................................................... 1295Linseed oil, virgin ................................................................... 2625Liothyronine sodium.............................................................. 2625Lipophilic solid dosage forms, dissolution test for(2.9.42.) .................................................................................... 361



Liquid chromatography (2.2.29.) .............................................. 45Liquid extracts .......................................................................... 745Liquid glucose ......................................................................... 2341Liquid glucose, spray-dried ................................................... 2342Liquid lactulose....................................................................... 2587Liquid maltitol ........................................................................ 2688Liquid paraffin ........................................................................ 2966Liquid preparations for cutaneous application ..................... 789Liquid preparations for cutaneous application, veterinary.. 814Liquid preparations for oral use ............................................. 790Liquids, clarity and degree of opalescence of (2.2.1.) ............ 21Liquid sorbitol (crystallising)................................................ 3286Liquid sorbitol (non-crystallising) ....................................... 3286Liquid sorbitol, partially dehydrated.................................... 3287Liquorice dry extract for flavouring purposes .................... 1296Liquorice ethanolic liquid extract, standardised ................ 1297Liquorice root ......................................................................... 1298Lisinopril dihydrate ................................................................ 2627Lithium carbonate .................................................................. 2628Lithium citrate ........................................................................ 2628L-Methionine ([11C]methyl) injection .................................. 1073Lobeline hydrochloride.......................................................... 2629Lomustine ................................................................................ 2630Long pepper ............................................................................ 1299Loosestrife ............................................................................... 1300Loperamide hydrochloride.................................................... 2631Loperamide oxide monohydrate........................................... 2633Lopinavir.................................................................................. 2634Loratadine................................................................................ 2638Lorazepam ............................................................................... 2639Losartan potassium ................................................................ 2641Loss on drying (2.2.32.) ............................................................. 52Loss on drying of extracts (2.8.17.) ........................................ 276Lovage root .............................................................................. 1301Lovastatin ................................................................................ 2643Low-molecular-mass heparins.............................................. 2392Lozenges and pastilles .............................................................. 795Lozenges, compressed .............................................................. 795Lubricant, silicone oil (3.1.8.).................................................. 393Lufenuron (anhydrous) for veterinary use .......................... 2644Lymecycline............................................................................. 2646Lynestrenol .............................................................................. 2648Lyophilisates, oral ..................................................................... 812Lysine acetate .......................................................................... 2649Lysine hydrochloride.............................................................. 2650

MMacrogol 15 hydroxystearate ................................................ 2655Macrogol 20 glycerol monostearate...................................... 2656Macrogol 30 dipolyhydroxystearate ..................................... 2657Macrogol 40 sorbitol heptaoleate.......................................... 2657Macrogol 6 glycerol caprylocaprate...................................... 2655Macrogol cetostearyl ether .................................................... 2658Macrogolglycerol cocoates..................................................... 2663Macrogolglycerol hydroxystearate ........................................ 2664Macrogolglycerol ricinoleate ................................................. 2665Macrogol lauryl ether............................................................. 2658Macrogol oleate....................................................................... 2659Macrogol oleyl ether............................................................... 2660Macrogol poly(vinyl alcohol) grafted copolymer ............... 2660Macrogols ................................................................................ 2665Macrogol stearate.................................................................... 2662Macrogol stearyl ether ........................................................... 2662Magaldrate ............................................................................... 2667Magnesium (2.4.6.)................................................................... 128Magnesium acetate tetrahydrate ........................................... 2668Magnesium aluminium silicate............................................. 1521Magnesium and alkaline-earth metals (2.4.7.)...................... 128Magnesium aspartate dihydrate............................................ 2669Magnesium carbonate, heavy................................................ 2670Magnesium carbonate, light .................................................. 2671Magnesium chloride 4.5-hydrate .......................................... 2671

Magnesium chloride hexahydrate ........................................ 2672Magnesium citrate, anhydrous.............................................. 2673Magnesium citrate dodecahydrate........................................ 2673Magnesium citrate nonahydrate ........................................... 2674Magnesium gluconate ............................................................ 2674Magnesium glycerophosphate............................................... 2675Magnesium hydroxide............................................................ 2676Magnesium lactate dihydrate ................................................ 2676Magnesium oxide, heavy ....................................................... 2677Magnesium oxide, light.......................................................... 2677Magnesium peroxide.............................................................. 2678Magnesium pidolate ............................................................... 2679Magnesium stearate................................................................ 2680Magnesium sulfate heptahydrate .......................................... 2682Magnesium trisilicate ............................................................. 2683Magnolia officinalis bark ....................................................... 1302Magnolia officinalis flower .................................................... 1304Maize oil, refined .................................................................... 2683Maize starch ............................................................................ 2684Maize starch (5.8.) .................................................................... 677Malathion................................................................................. 2685Maleic acid............................................................................... 2685Malic acid ................................................................................ 2686Mallow flower.......................................................................... 1305Mallow leaf .............................................................................. 1306Maltitol..................................................................................... 2687Maltitol, liquid ........................................................................ 2688Maltodextrin............................................................................ 2689Mandarin epicarp and mesocarp.......................................... 1307Mandarin oil............................................................................ 1308Manganese gluconate ............................................................. 2690Manganese glycerophosphate, hydrated .............................. 2691Manganese sulfate monohydrate .......................................... 2691Mannheimia vaccine (inactivated) for cattle......................... 986Mannheimia vaccine (inactivated) for sheep ........................ 987Mannitol .................................................................................. 2692Mannitol (5.8.) .......................................................................... 677Maprotiline hydrochloride .................................................... 2694Marbofloxacin for veterinary use ......................................... 2695Marek’s disease vaccine (live) .................................................. 989Marshmallow leaf ................................................................... 1309Marshmallow root .................................................................. 1310Mass spectrometry (2.2.43.) ...................................................... 69Mass spectrometry, inductively coupled plasma- (2.2.58.) ... 98Mass uniformity of delivered doses from multidose containers(2.9.27.) .................................................................................... 331

Mass uniformity of single-dose preparations (2.9.5.) .......... 297Mastic ....................................................................................... 1311Materials based on non-plasticised poly(vinyl chloride) forcontainers for dry dosage forms for oral administration(3.1.11.) .................................................................................... 397

Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions(3.1.10.) .................................................................................... 395

Materials based on plasticised poly(vinyl chloride) forcontainers for aqueous solutions for intravenous infusion(3.1.14.) .................................................................................... 401

Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components(3.1.1.1.) ................................................................................... 375

Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.)............................................................. 378

Materials for containers for human blood and bloodcomponents (3.1.1.)................................................................ 375

Materials used for the manufacture of containers (3.1.)...... 375Matricaria flower .................................................................... 1311Matricaria liquid extract ........................................................ 1313Matricaria oil........................................................................... 1314Meadowsweet .......................................................................... 1316Measles immunoglobulin, human ........................................ 2421Measles, mumps and rubella vaccine (live) ........................... 872Measles, mumps, rubella and varicella vaccine (live) .......... 873



Measles vaccine (live)............................................................... 874Measurement and detection of radioactivity (2.2.66.) ......... 110Measurement of consistency by penetrometry (2.9.9.)........ 299Mebendazole ........................................................................... 2696Meclozine dihydrochloride.................................................... 2698Medicated chewing gums ........................................................ 781Medicated chewing gums, dissolution test for (2.9.25.)....... 325Medicated feeding stuffs for veterinary use, premixes for .. 800Medicated foams....................................................................... 784Medicated plasters .................................................................... 809Medicated tampons .................................................................. 812Medicated vaginal tampons..................................................... 814Medicinal air ........................................................................... 1492Medicinal air, synthetic.......................................................... 1494Medium-chain triglycerides .................................................. 3471Medronic acid for radiopharmaceutical preparations ....... 1072Medroxyprogesterone acetate................................................ 2699Mefenamic acid....................................................................... 2701Mefloquine hydrochloride..................................................... 2702Megestrol acetate .................................................................... 2704Meglumine............................................................................... 2706Melilot ...................................................................................... 1317Melissa leaf .............................................................................. 1318Melissa leaf dry extract .......................................................... 1319Meloxicam ............................................................................... 2707Melphalan ................................................................................ 2708Melting point - capillary method (2.2.14.) .............................. 32Melting point - instantaneous method (2.2.16.) ..................... 32Melting point – instrumental method (2.2.60.) .................... 105Melting point - open capillary method (2.2.15.) .................... 32Menadione............................................................................... 2710Meningococcal group C conjugate vaccine ........................... 875Meningococcal polysaccharide vaccine ................................. 877Menthol, racemic .................................................................... 2711Mepivacaine hydrochloride ................................................... 2712Meprobamate .......................................................................... 2713Mepyramine maleate.............................................................. 2714Mercaptopurine ...................................................................... 2715Mercuric chloride ................................................................... 2715Mercury porosimetry, porosity and pore-size distribution ofsolids by (2.9.32.) .................................................................... 336

Meropenem trihydrate ........................................................... 2716Mesalazine ............................................................................... 2717Mesna ....................................................................................... 2720Mesterolone ............................................................................. 2721Mestranol ................................................................................. 2722Metabisulfite, potassium ........................................................ 3073Metabisulfite, sodium............................................................. 3254Metacresol................................................................................ 2723Metal catalyst or metal reagent residues (5.20.).................... 733Metal catalyst or metal reagent residues, determination of(2.4.20.) .................................................................................... 133

Metamizole sodium monohydrate........................................ 2724Metered-dose preparations for inhalation, non-pressurised............................................................................... 803

Metered-dose preparations for inhalation, pressurised ....... 801Metformin hydrochloride...................................................... 2725Methacrylate copolymer, basic butylated ............................ 1624Methacrylic acid - ethyl acrylate copolymer (1:1).............. 2727Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion30 per cent ............................................................................. 2728

Methacrylic acid - methyl methacrylate copolymer (1:1).. 2729Methacrylic acid - methyl methacrylate copolymer (1:2).. 2730Methadone hydrochloride ..................................................... 2731Methanesulfonate (methyl, ethyl and isopropyl) in activesubstances (2.5.38.)................................................................. 170

Methanesulfonic acid, methanesulfonyl chloride in(2.5.39.) .................................................................................... 171

Methanesulfonic acid, methyl, ethyl and isopropylmethanesulfonate in (2.5.37.)................................................ 169

Methanesulfonyl chloride in methanesulfonic acid(2.5.39.) .................................................................................... 171

Methanol.................................................................................. 2732

Methanol and 2-propanol, test for (2.9.11.) .......................... 304Methenamine .......................................................................... 2733Methionine .............................................................................. 2733Methionine ([11C]methyl) injection, L- ................................ 1073Methionine, DL- ...................................................................... 2734Methods in pharmacognosy (2.8.).......................................... 271Methods of preparation of homoeopathic stocks andpotentisation ......................................................................... 1431

Methods of preparation of sterile products (5.1.1.) ............. 555Methotrexate ........................................................................... 2735Methylcellulose ....................................................................... 2739Methylcellulose (5.8.) ............................................................... 677Methyldopa.............................................................................. 2741Methylene blue........................................................................ 2757Methylene chloride................................................................. 2743Methylergometrine maleate .................................................. 2744Methyl, ethyl and isopropyl methanesulfonate in activesubstances (2.5.38.)................................................................. 170

Methyl, ethyl and isopropyl methanesulfonate inmethanesulfonic acid (2.5.37.) .............................................. 169

Methylhydroxyethylcellulose................................................. 2745Methyl methacrylate - methacrylic acid copolymer (1:1).. 2729Methyl methacrylate - methacrylic acid copolymer (1:2).. 2730Methyl nicotinate.................................................................... 2737Methyl parahydroxybenzoate................................................ 2738Methyl parahydroxybenzoate, sodium................................. 3255Methylpentoses in polysaccharide vaccines (2.5.21.) ........... 161Methylphenidate hydrochloride ........................................... 2746Methylphenobarbital .............................................................. 2747Methylprednisolone................................................................ 2748Methylprednisolone acetate................................................... 2751Methylprednisolone hydrogen succinate ............................. 2753Methylpyrrolidone, N- ........................................................... 2754Methylrosanilinium chloride ................................................ 2755Methyl salicylate ..................................................................... 2739Methyltestosterone ................................................................. 2756Methylthioninium chloride ................................................... 2757Metixene hydrochloride......................................................... 2759Metoclopramide...................................................................... 2760Metoclopramide hydrochloride ............................................ 2761Metolazone .............................................................................. 2762Metoprolol succinate .............................................................. 2763Metoprolol tartrate ................................................................. 2765Metrifonate .............................................................................. 2766Metronidazole ......................................................................... 2768Metronidazole benzoate......................................................... 2769Mexiletine hydrochloride ...................................................... 2770Mianserin hydrochloride ....................................................... 2771Miconazole .............................................................................. 2773Miconazole nitrate.................................................................. 2774Microbial enumeration tests (microbiological examination ofnon-sterile products) (2.6.12.) .............................................. 185

Microbial enumeration tests (microbiological examination ofnon-sterile products) (2.6.12.) (5.8.).................................... 678

Microbiological assay of antibiotics (2.7.2.) .......................... 230Microbiological control of cellular products (2.6.27.) ......... 216Microbiological examination of herbal medicinal products fororal use and extracts used in their preparation (2.6.31.)... 222

Microbiological examination of non-sterile products :microbial enumeration tests (2.6.12.) .................................. 185

Microbiological examination of non-sterile products :microbial enumeration tests (2.6.12.) (5.8.)........................ 678

Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) ..................................... 189

Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) (5.8.)........................... 678

Microbiological quality, alternative methods for control of(5.1.6.) ...................................................................................... 560

Microbiological quality of herbal medicinal products for oraluse and extracts used in their preparation (5.1.8.)............. 571

Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use(5.1.4.) ...................................................................................... 559



Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use (5.1.4.)(5.8.) ......................................................................................... 679

Microbiology, general texts on (5.1.) ..................................... 555Microcalorimetry and solution calorimetry, characterisationof crystalline solids by (2.2.61.) ............................................ 106

Microcrystalline cellulose ...................................................... 1824Microcrystalline cellulose and carmellose sodium ............ 2776Micro determination of water (2.5.32.).................................. 164Microscopic examination of herbal drugs (2.8.23) .............. 282Microscopy, optical (2.9.37.) ................................................... 349Microscopy, optical (2.9.37.) (5.8.) ........................................ 679Midazolam............................................................................... 2777Milk thistle dry extract, refined and standardised ............. 1320Milk thistle fruit...................................................................... 1321Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts (5.2.8.)...................................................................... 592

Minocycline hydrochloride dihydrate.................................. 2779Minoxidil ................................................................................. 2780Mint oil, partly dementholised ............................................. 1323Mirtazapine ............................................................................. 2781Misoprostol.............................................................................. 2783Mitomycin ............................................................................... 2784Mitoxantrone hydrochloride ................................................. 2786Modafinil ................................................................................. 2787Modified-release capsules ........................................................ 780Modified-release granules........................................................ 786Modified-release tablets ........................................................... 811Mofetil mycophenolate .......................................................... 2808Molecular mass distribution in dextrans (2.2.39.).................. 60Molgramostim concentrated solution.................................. 2788Molsidomine ........................................................................... 2791Molybdate dihydrate, sodium ............................................... 3256Mometasone furoate............................................................... 2792Monoclonal antibodies for human use .................................. 753Monocyte-activation test (2.6.30.) .......................................... 217Monophosphoryl lipid A, 3-O-desacyl-4′- .......................... 2000Montelukast sodium............................................................... 2794Morantel hydrogen tartrate for veterinary use ................... 2796Morphine hydrochloride ....................................................... 2797Morphine sulfate..................................................................... 2799Moss, Iceland........................................................................... 1275Mother tinctures for homoeopathic preparations .............. 1440Motherwort ............................................................................. 1324Mouthwashes............................................................................. 794Moxidectin for veterinary use............................................... 2800Moxifloxacin hydrochloride .................................................. 2803Moxonidine ............................................................................. 2804Mucoadhesive preparations..................................................... 796Mullein flower ......................................................................... 1325Multidose containers, uniformity of mass of delivered doses(2.9.27.) .................................................................................... 331

Mumps, measles and rubella vaccine (live)........................... 872Mumps, measles, rubella and varicella vaccine (live) .......... 873Mumps vaccine (live) ............................................................... 879Mupirocin ................................................................................ 2805Mupirocin calcium ................................................................. 2807Mycobacteria (2.6.2.)................................................................ 178Mycophenolate mofetil .......................................................... 2808Mycoplasma gallisepticum vaccine (inactivated) ................. 990Mycoplasmas (2.6.7.)................................................................ 178myo-Inositol ............................................................................ 2810Myrrh ....................................................................................... 1326Myrrh tincture ........................................................................ 1327Myxomatosis vaccine (live) for rabbits .................................. 991

NNabumetone ............................................................................ 2813N-Acetyltryptophan ............................................................... 1479N-Acetyltyrosine ..................................................................... 1481Nadolol..................................................................................... 2814

Nadroparin calcium ............................................................... 2815Naftidrofuryl hydrogen oxalate ............................................ 2817Nalidixic acid .......................................................................... 2819Naloxone hydrochloride dihydrate....................................... 2820Naltrexone hydrochloride...................................................... 2822Nandrolone decanoate ........................................................... 2824Naphazoline hydrochloride ................................................... 2825Naphazoline nitrate ................................................................ 2826Naproxen ................................................................................. 2827Naproxen sodium ................................................................... 2829Narrow-leaved coneflower root ............................................ 1327Nasal drops and liquid nasal sprays ....................................... 792Nasal powders ........................................................................... 793Nasal preparations .................................................................... 792Nasal preparations, semi-solid................................................ 793Nasal sprays (liquid) and nasal drops .................................... 792Nasal sticks ................................................................................ 793Nasal washes.............................................................................. 793Nateglinide .............................................................................. 2831Near-infrared spectroscopy (2.2.40.)........................................ 62Nebulisation, characterisation of preparations for(2.9.44.) .................................................................................... 363

Nebulisation, liquid preparations for ..................................... 801Neohesperidin-dihydrochalcone .......................................... 2833Neomycin sulfate .................................................................... 2834Neonatal piglet colibacillosis vaccine (inactivated).............. 992Neonatal ruminant colibacillosis vaccine (inactivated)....... 994Neostigmine bromide............................................................. 2836Neostigmine metilsulfate ....................................................... 2837Neroli oil .................................................................................. 1329Netilmicin sulfate.................................................................... 2837Nettle leaf................................................................................. 1331Neurovirulence test for poliomyelitis vaccine (oral)(2.6.19.) .................................................................................... 202

Neurovirulence test of live viral vaccines (2.6.18.) ............... 202Nevirapine, anhydrous ........................................................... 2839Nevirapine hemihydrate ........................................................ 2840Newcastle disease vaccine (inactivated)................................. 995Newcastle disease vaccine (live).............................................. 997Niaouli oil, cineole type ......................................................... 1332Nicergoline .............................................................................. 2841Nickel in hydrogenated vegetable oils (2.4.31.) .................... 150Nickel in polyols (2.4.15.) ........................................................ 132Niclosamide, anhydrous ........................................................ 2843Niclosamide monohydrate .................................................... 2844Nicotinamide........................................................................... 2845Nicotine.................................................................................... 2845Nicotine ditartrate dihydrate................................................. 2846Nicotine resinate ..................................................................... 2847Nicotinic acid .......................................................................... 2849Nifedipine ................................................................................ 2850Niflumic acid........................................................................... 2851Nifuroxazide............................................................................ 2853Nikethamide............................................................................ 2854Nilutamide............................................................................... 2855Nimesulide............................................................................... 2856Nimodipine ............................................................................. 2857Nitrazepam .............................................................................. 2858Nitrendipine ............................................................................ 2859Nitric acid ................................................................................ 2860Nitric oxide.............................................................................. 2861Nitrofural ................................................................................. 2862Nitrofurantoin......................................................................... 2863Nitrogen ................................................................................... 2863Nitrogen determination by sulfuric acid digestion (2.5.9.).. 157Nitrogen determination, primary aromatic amino (2.5.8.).. 157Nitrogen, low-oxygen............................................................. 2864Nitrogen monoxide and nitrogen dioxide in gases(2.5.26.) .................................................................................... 163

Nitroprusside, sodium ........................................................... 3257Nitrous oxide........................................................................... 2865Nitrous oxide in gases (2.5.35.)............................................... 168Nizatidine ................................................................................ 2866



N-Methylpyrrolidone ............................................................. 2754NMR spectrometry (2.2.33.) ..................................................... 52NMR spectrometry, peptide identification by (2.2.64.)....... 109N,N-Dimethylaniline (2.4.26.) ................................................ 146Nomegestrol acetate ............................................................... 2868Nonoxinol 9............................................................................. 2869Non-sterile pharmaceutical preparations and substances forpharmaceutical use, microbiological quality of (5.1.4.)..... 559

Non-sterile pharmaceutical preparations and substancesfor pharmaceutical use, microbiological quality of (5.1.4.)(5.8.) ......................................................................................... 679

Non-sterile products, microbiological examination of(microbial enumeration tests) (2.6.12.) ............................... 185

Non-sterile products, microbiological examination of(microbial enumeration tests) (2.6.12.) (5.8.)..................... 678

Non-sterile products, microbiological examination of (test forspecified micro-organisms) (2.6.13.).................................... 189

Non-sterile products, microbiological examination of (test forspecified micro-organisms) (2.6.13.) (5.8.) ......................... 678

Noradrenaline hydrochloride................................................ 2869Noradrenaline tartrate ........................................................... 2871Norepinephrine hydrochloride ............................................. 2869Norepinephrine tartrate......................................................... 2871Norethisterone ........................................................................ 2872Norethisterone acetate ........................................................... 2874Norfloxacin.............................................................................. 2875Norflurane ............................................................................... 2877Norgestimate ........................................................................... 2883Norgestrel ................................................................................ 2884Normal immunoglobulin for intravenous administration,human .................................................................................... 2423

Normal immunoglobulin, human ........................................ 2421Nortriptyline hydrochloride.................................................. 2884Noscapine ................................................................................ 2886Noscapine hydrochloride....................................................... 2887Notoginseng root .................................................................... 1333Nuclear magnetic resonance spectrometry (2.2.33.).............. 52Nuclear magnetic resonance spectrometry, peptideidentification by (2.2.64.)....................................................... 109

Nucleated cell count and viability (2.7.29.) ........................... 263Nucleic acid amplification techniques (2.6.21.) .................... 204Nucleic acids in polysaccharide vaccines (2.5.17.) ............... 160Numeration of CD34/CD45+ cells in haematopoietic products(2.7.23.) .................................................................................... 258

Nutmeg oil ............................................................................... 1334Nystatin.................................................................................... 2888

OO-Acetyl in polysaccharide vaccines (2.5.19.)....................... 160Oak bark .................................................................................. 1335Octoxinol 10............................................................................ 2893Octyldodecanol ....................................................................... 2894Octyl gallate............................................................................. 2893Odour (2.3.4.)............................................................................ 123Odour and taste of essential oils (2.8.8.)................................ 272Ofloxacin.................................................................................. 2895Oils, essential............................................................................. 743Oils, fatty, identification by thin-layer chromatography(2.3.2.) ...................................................................................... 122

Oils, fatty, vegetable.................................................................. 775Oils rich in omega-3 acids, composition of fatty acids in(2.4.29.) .................................................................................... 148

Oils rich in omega-3 acids, total cholesterol in (2.4.32.) ..... 151Ointments .................................................................................. 808Olanzapine............................................................................... 2896Oleic acid ................................................................................. 2898Oleoresins .................................................................................. 746Oleoyl macrogolglycerides .................................................... 2898Oleyl alcohol............................................................................ 2899Olive leaf .................................................................................. 1335Olive leaf dry extract .............................................................. 1337Olive oil, refined ..................................................................... 2899

Olive oil, virgin ....................................................................... 2900Olmesartan medoxomil ......................................................... 2901Olsalazine sodium .................................................................. 2903Omega-3-acid ethyl esters 60 ................................................ 2905Omega-3-acid ethyl esters 90 ................................................ 2907Omega-3 acids, composition of fatty acids in oils rich in(2.4.29.) .................................................................................... 148

Omega-3 acids, fish oil rich in .............................................. 2236Omega-3 acids, total cholesterol in oils rich in (2.4.32.) ..... 151Omega-3-acid triglycerides ................................................... 2909Omeprazole ............................................................................. 2911Omeprazole magnesium........................................................ 2912Omeprazole sodium ............................................................... 2913Ondansetron hydrochloride dihydrate ................................ 2915Opalescence of liquids, clarity and degree of (2.2.1.)............. 21Ophthalmic inserts ................................................................... 784Opium dry extract, standardised.......................................... 1337Opium, prepared .................................................................... 1339Opium, raw.............................................................................. 1340Opium tincture, standardised ............................................... 1341Optical microscopy (2.9.37.) ................................................... 349Optical microscopy (2.9.37.) (5.8.)......................................... 679Optical rotation (2.2.7.) ............................................................. 26Oral drops.................................................................................. 791Oral lyophilisates ...................................................................... 812Oral powders............................................................................. 799Oral solutions, emulsions and suspensions........................... 790Oral use, liquid preparations for ............................................ 790Orbifloxacin for veterinary use............................................. 2916Orciprenaline sulfate .............................................................. 2918Oregano ................................................................................... 1342Organ preservation, solutions for......................................... 3273Oriental cashew for homoeopathic preparations ............... 1453Orientvine stem ...................................................................... 1344Orodispersible films ................................................................. 796Orodispersible tablets .............................................................. 811Oromucosal capsules................................................................ 795Oromucosal drops, oromucosal sprays and sublingualsprays........................................................................................ 794

Oromucosal preparations ........................................................ 793Oromucosal preparations, semi-solid .................................... 794Oromucosal solutions and oromucosal suspensions............ 794Oromucosal sprays, oromucosal drops and sublingualsprays........................................................................................ 793

Oromucosal suspensions and oromucosal solutions............ 793Orphenadrine citrate.............................................................. 2919Orphenadrine hydrochloride ................................................ 2921Oseltamivir phosphate ........................................................... 2922Osmolality (2.2.35.) .................................................................... 57Ouabain ................................................................................... 2924Oxacillin sodium monohydrate ............................................ 2925Oxaliplatin ............................................................................... 2927Oxazepam................................................................................ 2929Oxcarbazepine......................................................................... 2931Oxeladin hydrogen citrate ..................................................... 2932Oxfendazole for veterinary use ............................................. 2933Oxidising substances (2.5.30.)................................................. 164Oxitropium bromide .............................................................. 2934Oxolinic acid ........................................................................... 2936Oxprenolol hydrochloride ..................................................... 2937Oxybuprocaine hydrochloride .............................................. 2938Oxybutynin hydrochloride .................................................... 2939Oxycodone hydrochloride ..................................................... 2940Oxygen ..................................................................................... 2941Oxygen (15O) ........................................................................... 1074Oxygen (93 per cent).............................................................. 2942Oxygen-flask method (2.5.10.)................................................ 158Oxygen in gases (2.5.27.) ......................................................... 163Oxymetazoline hydrochloride............................................... 2943Oxytetracycline dihydrate...................................................... 2945Oxytetracycline hydrochloride.............................................. 2946Oxytocin .................................................................................. 2948Oxytocin concentrated solution............................................ 2949



PPaclitaxel .................................................................................. 2953Pale coneflower root............................................................... 1345Palmitic acid............................................................................ 2956Pamidronate disodium pentahydrate................................... 2956Pancreas powder ..................................................................... 2957Pancuronium bromide ........................................................... 2959Panleucopenia vaccine (inactivated), feline .......................... 973Panleucopenia vaccine (live), feline ....................................... 974Pansy, wild (flowering aerial parts)...................................... 1420Pantoprazole sodium sesquihydrate..................................... 2960Pantothenate, calcium............................................................ 1749Papaverine hydrochloride...................................................... 2962Paper chromatography (2.2.26.) ............................................... 42Papillomavirus vaccine (rDNA), human .............................. 859Paraben, butyl ......................................................................... 1712Paraben, ethyl.......................................................................... 2191Paraben, methyl ...................................................................... 2738Paraben, propyl ....................................................................... 3122Paraben, sodium ethyl............................................................ 3243Paraben, sodium methyl ........................................................ 3255Paraben, sodium propyl......................................................... 3263Paracetamol ............................................................................. 2963Paraffin, hard........................................................................... 2964Paraffin, light liquid ............................................................... 2965Paraffin, liquid ........................................................................ 2966Paraffin, white soft.................................................................. 2966Paraffin, yellow soft ................................................................ 2967Parahydroxybenzoate, butyl .................................................. 1712Parahydroxybenzoate, ethyl .................................................. 2191Parahydroxybenzoate, methyl ............................................... 2738Parahydroxybenzoate, propyl................................................ 3122Parahydroxybenzoate, sodium ethyl .................................... 3243Parahydroxybenzoate, sodium methyl................................. 3255Parahydroxybenzoate, sodium propyl.................................. 3263Parainfluenza virus vaccine (live), bovine ............................. 938Parainfluenza virus vaccine (live), canine ............................. 949Paraldehyde ............................................................................. 2968Paramyxovirus 1 (Newcastle disease) vaccine (inactivated),avian ......................................................................................... 995

Paramyxovirus 1 (Newcastle disease) vaccine (live), avian.. 997Paramyxovirus 3 vaccine (inactivated) for turkeys, avian ... 934Parenteral preparations............................................................ 796Parenteral preparations, test for extractable volume of(2.9.17.) .................................................................................... 308

Parenteral preparations, test for extractable volume of (2.9.17.)(5.8.) ......................................................................................... 679

Parnaparin sodium................................................................. 2968Paroxetine hydrochloride, anhydrous .................................. 2969Paroxetine hydrochloride hemihydrate ............................... 2971Particles, fine, aerodynamic assessment of in preparations forinhalation (2.9.18.) ................................................................. 309

Particle size analysis by laser light diffraction (2.9.31.) ....... 333Particle-size distribution estimation by analytical sieving(2.9.38.) .................................................................................... 351

Particle-size distribution estimation by analytical sieving(2.9.38.) (5.8.).......................................................................... 679

Particulate contamination : sub-visible particles (2.9.19.) ... 321Particulate contamination : sub-visible particles (2.9.19.)(5.8.) ......................................................................................... 679

Particulate contamination : visible particles (2.9.20.)........... 323Parvovirosis vaccine (inactivated), canine............................. 950Parvovirosis vaccine (inactivated), porcine......................... 1004Parvovirosis vaccine (live), canine.......................................... 951Passion flower ......................................................................... 1347Passion flower dry extract ..................................................... 1347Pastes .......................................................................................... 809Pasteurella vaccine (inactivated) for sheep............................ 999Pastilles and lozenges ............................................................... 795Patches, cutaneous.................................................................... 807Patches, transdermal ................................................................ 798Patches, transdermal, dissolution test for (2.9.4.)................. 295

Pea starch................................................................................. 2973Pefloxacin mesilate dihydrate................................................ 2973Pelargonium root .................................................................... 1348Pemetrexed disodium heptahydrate..................................... 2975Penbutolol sulfate ................................................................... 2977Penetrometry, measurement of consistency by (2.9.9.) ....... 299Penicillamine........................................................................... 2978Penicillin G, benzathine......................................................... 1647Penicillin G potassium........................................................... 1648Penicillin G, procaine............................................................. 1650Penicillin G sodium................................................................ 1651Penicillin V.............................................................................. 3006Penicillin V potassium ........................................................... 3007Pentaerythrityl tetranitrate, diluted...................................... 2980Pentamidine diisetionate ....................................................... 2982Pentazocine.............................................................................. 2982Pentazocine hydrochloride .................................................... 2983Pentazocine lactate ................................................................. 2984Pentetate sodium calcium for radiopharmaceuticalpreparations .......................................................................... 1075

Pentobarbital ........................................................................... 2984Pentobarbital sodium ............................................................. 2985Pentoxifylline .......................................................................... 2986Pentoxyverine hydrogen citrate ............................................ 2988Pepper ...................................................................................... 1349Pepper, long............................................................................. 1299Peppermint leaf....................................................................... 1350Peppermint leaf dry extract................................................... 1352Peppermint oil ........................................................................ 1353Pepsin powder......................................................................... 2989Peptide identification by nuclear magnetic resonancespectrometry (2.2.64.) ............................................................ 109

Peptide mapping (2.2.55.).......................................................... 87Peptide mapping (2.2.55.) (5.8.) ............................................. 677Peptides, synthetic, acetic acid in (2.5.34.) ............................ 168Perborate, hydrated sodium .................................................. 3258Pergolide mesilate ................................................................... 2990Perindopril tert-butylamine .................................................. 2991Peritoneal dialysis, solutions for ........................................... 2994Peroxide value (2.5.5.) .............................................................. 156Perphenazine........................................................................... 2996Pertussis (acellular, component), diphtheria and tetanusvaccine (adsorbed) ................................................................. 826

Pertussis (acellular, component), diphtheria, tetanus andhaemophilus type b conjugate vaccine (adsorbed) ............ 830

Pertussis (acellular, component), diphtheria, tetanus andhepatitis B (rDNA) vaccine (adsorbed) ............................... 832

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed)................... 834

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ................................................................. 835

Pertussis (acellular, component), diphtheria, tetanus,hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ............ 837

Pertussis (acellular, component), diphtheria, tetanus,poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed) ................................................................. 840

Pertussis toxin (residual) and pertussis toxoid (irreversibilityof) (2.6.33.).............................................................................. 224

Pertussis vaccine (acellular), assay of (2.7.16.)...................... 252Pertussis vaccine (acellular, component, adsorbed)............. 880Pertussis vaccine (acellular, co-purified, adsorbed) ............. 882Pertussis vaccine (whole cell, adsorbed)................................ 883Pertussis vaccine (whole cell), assay of (2.7.7.) ..................... 242Pertussis (whole cell), diphtheria and tetanus vaccine(adsorbed) ............................................................................... 827

Pertussis (whole cell), diphtheria, tetanus and poliomyelitis(inactivated) vaccine (adsorbed) .......................................... 842

Pertussis (whole cell), diphtheria, tetanus, poliomyelitis(inactivated) and haemophilus type b conjugate vaccine(adsorbed) ............................................................................... 844

Peru balsam ............................................................................. 1354



Pessaries ..................................................................................... 813Pessaries and suppositories, disintegration of (2.9.2.) ......... 287Pesticide residues (2.8.13.)....................................................... 274Pethidine hydrochloride ........................................................ 2997Pharmaceutical preparations................................................... 756Pharmaceutical technical procedures (2.9.) .......................... 285Pharmacognosy, methods in (2.8.)......................................... 271Pharmacopoeial harmonisation (5.8.) ................................... 677Phenazone................................................................................ 2999Pheniramine maleate.............................................................. 3000Phenobarbital .......................................................................... 3001Phenobarbital sodium............................................................ 3002Phenol ...................................................................................... 3003Phenol in immunosera and vaccines (2.5.15.) ...................... 159Phenolphthalein...................................................................... 3003Phenolsulfonphthalein ........................................................... 3004Phenothiazines, identification by thin-layer chromatography(2.3.3.) ...................................................................................... 123

Phenoxyethanol ...................................................................... 3005Phenoxymethylpenicillin ....................................................... 3006Phenoxymethylpenicillin potassium .................................... 3007Phentolamine mesilate ........................................................... 3009Phenylalanine .......................................................................... 3010Phenylbutazone....................................................................... 3011Phenylbutyrate, sodium ......................................................... 3258Phenylephrine ......................................................................... 3013Phenylephrine hydrochloride................................................ 3014Phenylmercuric acetate .......................................................... 3015Phenylmercuric borate........................................................... 3016Phenylmercuric nitrate .......................................................... 3016Phenylpropanolamine hydrochloride .................................. 3017Phenytoin................................................................................. 3017Phenytoin sodium................................................................... 3019Phloroglucinol, anhydrous .................................................... 3020Phloroglucinol dihydrate ....................................................... 3022Pholcodine............................................................................... 3024Phosphates (2.4.11.).................................................................. 131Phosphoric acid, concentrated.............................................. 3025Phosphoric acid, dilute .......................................................... 3025Phosphorus in polysaccharide vaccines (2.5.18.) ................. 160pH, potentiometric determination of (2.2.3.) ......................... 24Phthalylsulfathiazole .............................................................. 3026Physical and physicochemical methods (2.2.) ........................ 21Physostigmine salicylate ........................................................ 3027Phytomenadione ..................................................................... 3027Phytosterol............................................................................... 3029Picosulfate, sodium ................................................................ 3260Picotamide monohydrate....................................................... 3030Piglet colibacillosis vaccine (inactivated), neonatal ............. 992Pillules for homoeopathic preparations............................... 1441Pillules, homoeopathic, impregnated................................... 1441Pilocarpine hydrochloride ..................................................... 3031Pilocarpine nitrate .................................................................. 3032Pimobendan ............................................................................ 3033Pimozide .................................................................................. 3034Pindolol.................................................................................... 3036Pine (dwarf) oil....................................................................... 1230Pine sylvestris oil .................................................................... 1355Pinus pinaster type turpentine oil ........................................ 1411Pioglitazone hydrochloride ................................................... 3037Pipemidic acid trihydrate ...................................................... 3038Piperacillin............................................................................... 3039Piperacillin sodium ................................................................ 3041Piperazine adipate .................................................................. 3042Piperazine citrate .................................................................... 3043Piperazine hydrate .................................................................. 3044Piracetam................................................................................. 3045Pirenzepine dihydrochloride monohydrate ........................ 3046Piretanide................................................................................. 3047Piroxicam................................................................................. 3048Pivampicillin ........................................................................... 3050Pivmecillinam hydrochloride................................................ 3051Plasma for fractionation, human.......................................... 2425

Plasma (pooled and treated for virus inactivation),human .................................................................................... 2426

Plasmid vectors for human use, bacterial cells used for themanufacture of........................................................................ 707

Plasmin inhibitor, assay of human (2.7.25.).......................... 261Plasters, medicated ................................................................... 807Plastic additives (3.1.13.) ......................................................... 398Plastic containers and closures for pharmaceutical use(3.2.2.) ...................................................................................... 414

Plastic containers for aqueous solutions for infusion(3.2.2.1.) ................................................................................... 414

Plastic containers for human blood and blood components,sterile (3.2.3.)........................................................................... 415

Plastic syringes, single-use, sterile (3.2.8.)............................. 419Pneumococcal polysaccharide conjugate vaccine(adsorbed) ............................................................................... 885

Pneumococcal polysaccharide vaccine .................................. 887Pneumonia vaccine (inactivated), porcine enzootic .......... 1001Poliomyelitis (inactivated), diphtheria and tetanus vaccine(adsorbed, reduced antigen(s) content)............................... 829

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ......................... 834

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed, reduced antigen(s)content).................................................................................... 835

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(whole cell) vaccine (adsorbed) ............................................ 842

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component) and haemophilus type b conjugatevaccine (adsorbed) ................................................................. 840

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and haemophilustype b conjugate vaccine (adsorbed) .................................... 837

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(whole cell) and haemophilus type b conjugate vaccine(adsorbed) ............................................................................... 844

Poliomyelitis vaccine (inactivated) ......................................... 889Poliomyelitis vaccine (inactivated), in vivo assay of(2.7.20.) .................................................................................... 255

Poliomyelitis vaccine (oral) ..................................................... 891Poliomyelitis vaccine (oral), test for neurovirulence(2.6.19.) .................................................................................... 202

Poloxamers .............................................................................. 3052Polyacrylate dispersion 30 per cent ...................................... 3054Polyamide 6/6 suture, sterile, in distributor for veterinary use................................................................................................ 1128

Polyamide 6 suture, sterile, in distributor for veterinary use................................................................................................ 1128

Polyethyleneglycols................................................................. 2665Polyethylene terephthalate for containers for preparations notfor parenteral use (3.1.15.) .................................................... 403

Poly(ethylene terephthalate) suture, sterile, in distributor forveterinary use ....................................................................... 1129

Poly(ethylene - vinyl acetate) for containers and tubing fortotal parenteral nutrition preparations (3.1.7.)................... 391

Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.5.)...... 384

Polyethylene without additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.4.)...... 383

Polymorphism (5.9.)................................................................. 685Polymyxin B sulfate ................................................................ 3055Polyolefins (3.1.3.) .................................................................... 380Polyoxyl castor oil................................................................... 2665Polyoxyl hydrogenated castor oil .......................................... 2664Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations (3.1.6.)............ 388

Polysaccharide vaccines, hexosamines in (2.5.20.) ............... 160Polysaccharide vaccines, methylpentoses in (2.5.21.) .......... 161Polysaccharide vaccines, nucleic acids in (2.5.17.) ............... 160Polysaccharide vaccines, O-acetyl in (2.5.19.)....................... 160Polysaccharide vaccines, phosphorus in (2.5.18.)................. 160Polysaccharide vaccines, protein in (2.5.16.)......................... 159Polysaccharide vaccines, ribose in (2.5.31.) .......................... 164



Polysaccharide vaccines, sialic acid in (2.5.23.) .................... 161Polysaccharide vaccines, uronic acids in (2.5.22.) ................ 161Polysorbate 20 ......................................................................... 3056Polysorbate 40 ......................................................................... 3057Polysorbate 60 ......................................................................... 3058Polysorbate 80 ......................................................................... 3058Polystyrene sulfonate, sodium .............................................. 3261Poly(vinyl acetate) .................................................................. 3060Poly(vinyl acetate) dispersion 30 per cent ........................... 3061Poly(vinyl alcohol).................................................................. 3062Poly(vinyl alcohol) macrogol grafted copolymer ............... 2660Poly(vinyl chloride) (non-plasticised) for containers for drydosage forms for oral administration, materials based on(3.1.11.) .................................................................................... 397

Poly(vinyl chloride), non-plasticised, materials based on forcontainers for non-injectable aqueous solutions (3.1.10.).. 395

Poly(vinyl chloride), plasticised, empty sterile containers offor human blood and blood components (3.2.4.) .............. 417

Poly(vinyl chloride), plasticised, materials based on forcontainers for aqueous solutions for intravenous infusion(3.1.14.) .................................................................................... 401

Poly(vinyl chloride), plasticised, materials based on forcontainers for human blood and blood components(3.1.1.1.) ................................................................................... 375

Poly(vinyl chloride), plasticised, materials based on fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.)............................................................. 378

Poly(vinyl chloride), plasticised, sterile containers of forhuman blood containing anticoagulant solution (3.2.5.) .. 418

Poppy petals, red..................................................................... 1363Porcine actinobacillosis vaccine (inactivated) .................... 1000Porcine enzootic pneumonia vaccine (inactivated) ........... 1001Porcine influenza vaccine (inactivated) ............................... 1003Porcine insulin ........................................................................ 2497Porcine parvovirosis vaccine (inactivated).......................... 1004Porcine progressive atrophic rhinitis vaccine(inactivated) .......................................................................... 1005

Pore-size distribution of solids by mercury porosimetry,porosity and (2.9.32.) ............................................................. 336

Poria ......................................................................................... 1356Porosimetry, mercury, porosity and pore-size distribution ofsolids by (2.9.32.) .................................................................... 336

Porosity and pore-size distribution of solids by mercuryporosimetry (2.9.32.).............................................................. 336

Porosity of sintered-glass filters (2.1.2.) ................................... 15Porous solids including powders, wettability of (2.9.45.) .... 365Potassium (2.4.12.) ................................................................... 132Potassium acetate.................................................................... 3063Potassium bromide................................................................. 3063Potassium carbonate............................................................... 3064Potassium chloride ................................................................. 3065Potassium citrate..................................................................... 3065Potassium clavulanate ............................................................ 3066Potassium clavulanate, diluted.............................................. 3068Potassium dichromate for homoeopathic preparations..... 1454Potassium dihydrogen phosphate......................................... 3070Potassium disulfite.................................................................. 3073Potassium hydrogen aspartate hemihydrate ....................... 3070Potassium hydrogen carbonate ............................................. 3071Potassium hydrogen tartrate ................................................. 3072Potassium hydroxide .............................................................. 3072Potassium iodide..................................................................... 3073Potassium metabisulfite ......................................................... 3073Potassium nitrate .................................................................... 3074Potassium perchlorate ............................................................ 3075Potassium permanganate....................................................... 3075Potassium sodium tartrate tetrahydrate .............................. 3076Potassium sorbate ................................................................... 3076Potassium sulfate .................................................................... 3077Potato starch............................................................................ 3078Potato starch (5.8.).................................................................... 677Potentiometric determination of ionic concentration usingion-selective electrodes (2.2.36.)............................................. 58

Potentiometric determination of pH (2.2.3.) .......................... 24Potentiometric titration (2.2.20.).............................................. 34Potentisation, methods of preparation of homoeopathic stocksand.......................................................................................... 1431

Poultices ..................................................................................... 809Pour-on preparations ............................................................... 814Povidone .................................................................................. 3078Povidone, iodinated................................................................ 3081Powdered cellulose ................................................................. 1828Powder fineness (2.9.35.) ......................................................... 346Powder flow (2.9.36.)................................................................ 346Powder flow (2.9.36.) (5.8.) ..................................................... 679Powders and granules for oral solutions and suspensions .. 791Powders and granules for syrups ............................................ 791Powders and tablets for rectal solutions and suspensions... 807Powders, bulk density and tapped density of (2.9.34.)......... 343Powders, ear .............................................................................. 782Powders, effervescent ............................................................... 800Powders for cutaneous application......................................... 799Powders for eye drops and powders for eye lotions ............. 784Powders for injections or infusions........................................ 797Powders for oral drops............................................................. 791Powders, inhalation .................................................................. 803Powders, nasal ........................................................................... 793Powders, oral ............................................................................. 799Powders, wettability of porous solids including (2.9.45.) .... 365Pramipexole dihydrochloride monohydrate ....................... 3082Pravastatin sodium................................................................. 3083Prazepam ................................................................................. 3085Praziquantel............................................................................. 3086Prazosin hydrochloride.......................................................... 3087Prednicarbate .......................................................................... 3088Prednisolone............................................................................ 3090Prednisolone acetate............................................................... 3091Prednisolone pivalate ............................................................. 3093Prednisolone sodium phosphate........................................... 3094Prednisone............................................................................... 3095Pregelatinised hydroxypropyl starch .................................... 3305Pregelatinised starch............................................................... 3306Prekallikrein activator (2.6.15.)............................................... 198Premixes for medicated feeding stuffs for veterinary use ... 800Preparations for inhalation ..................................................... 800Preparations for inhalation : aerodynamic assessment of fineparticles (2.9.18.) .................................................................... 309

Preparations for irrigation....................................................... 805Preparations for nebulisation : characterisation (2.9.44.) .... 363Pressurised pharmaceutical preparations .............................. 805Prilocaine................................................................................. 3097Prilocaine hydrochloride ....................................................... 3098Primaquine diphosphate........................................................ 3099Primary aromatic amino-nitrogen, determination of(2.5.8.) ...................................................................................... 157

Primary standards for volumetric solutions (4.2.1.) ............ 545Primidone ................................................................................ 3101Primula root ............................................................................ 1356Probenecid............................................................................... 3102Procainamide hydrochloride................................................. 3102Procaine benzylpenicillin ...................................................... 1650Procaine hydrochloride.......................................................... 3103Prochlorperazine maleate ...................................................... 3104Products of fermentation......................................................... 758Products of recombinant DNA technology........................... 763Products with risk of transmitting agents of animal spongiformencephalopathies .................................................................... 759

Progenitor cells, human haematopoietic, colony-forming cellassay for (2.7.28.) .................................................................... 262

Progesterone............................................................................ 3105Progressive atrophic rhinitis vaccine (inactivated),porcine ................................................................................... 1005

Proguanil hydrochloride........................................................ 3106Proline...................................................................................... 3107Promazine hydrochloride ...................................................... 3108Promethazine hydrochloride................................................. 3109



Propacetamol hydrochloride................................................. 3110Propafenone hydrochloride................................................... 3112Propanol................................................................................... 3113Propanol and methanol, 2-, test for (2.9.11.) ........................ 304Propantheline bromide .......................................................... 3114Propofol ................................................................................... 3115Propranolol hydrochloride .................................................... 3117Propylene glycol...................................................................... 3118Propylene glycol dicaprylocaprate........................................ 3118Propylene glycol dilaurate ..................................................... 3119Propylene glycol monolaurate............................................... 3120Propylene glycol monopalmitostearate................................ 3121Propylene glycol monostearate ............................................. 3121Propyl gallate........................................................................... 3121Propyl parahydroxybenzoate................................................. 3122Propyl parahydroxybenzoate, sodium ................................. 3263Propylthiouracil ...................................................................... 3124Propyphenazone ..................................................................... 3124Protamine sulfate .................................................................... 3125Protein C, human, assay of (2.7.30.)....................................... 265Protein in polysaccharide vaccines (2.5.16.) ......................... 159Protein S, human, assay of (2.7.31.) ....................................... 266Protein, total (2.5.33.) .............................................................. 165Prothrombin complex, human.............................................. 2429Protirelin.................................................................................. 3127Proxyphylline .......................................................................... 3128Pseudoephedrine hydrochloride........................................... 3129Psyllium seed........................................................................... 1357Purified water .......................................................................... 3561Purified water, highly............................................................. 3559Purple coneflower herb.......................................................... 1357Purple coneflower root .......................................................... 1359Pycnometric density of solids, gas (2.9.23.) .......................... 324Pygeum africanum bark ........................................................ 1361Pyrantel embonate.................................................................. 3130Pyrazinamide .......................................................................... 3131Pyridostigmine bromide ........................................................ 3132Pyridoxine hydrochloride...................................................... 3133Pyrimethamine ....................................................................... 3134Pyrogens (2.6.8.) ....................................................................... 183Pyrrolidone.............................................................................. 3135

QQuality of non-sterile pharmaceutical preparations andsubstances for pharmaceutical use, microbiological(5.1.4.) ...................................................................................... 559

Quality of non-sterile pharmaceutical preparations andsubstances for pharmaceutical use, microbiological (5.1.4.)(5.8.) ......................................................................................... 679

Quantified hawthorn leaf and flower liquid extract ........... 1274Quillaia bark............................................................................ 1362Quinapril hydrochloride........................................................ 3139Quinidine sulfate .................................................................... 3141Quinine hydrochloride .......................................................... 3142Quinine sulfate........................................................................ 3144

RRabbit haemorrhagic disease vaccine (inactivated) ........... 1007Rabies immunoglobulin, human .......................................... 2431Rabies vaccine for human use prepared in cell cultures...... 896Rabies vaccine (inactivated) for veterinary use .................. 1008Rabies vaccine (live, oral) for foxes and raccoon dogs ...... 1011Racecadotril............................................................................. 3149Racementhol............................................................................ 2711Racemic camphor ................................................................... 1753Racemic ephedrine hydrochloride ....................................... 2143Racemic menthol .................................................................... 2711Racephedrine hydrochloride................................................. 2143Raclopride ([11C]methoxy) injection.................................... 1076Radioactivity, detection and measurement of (2.2.66.) ....... 110Radionuclides, table of physical characteristics (5.7.).......... 667Radiopharmaceutical preparations ........................................ 759

Radiopharmaceutical preparations, iobenguane sulfatefor ........................................................................................... 1070

Radiopharmaceutical preparations, medronic acid for ..... 1072Radiopharmaceutical preparations, pentetate sodium calciumfor ........................................................................................... 1075

Radiopharmaceutical preparations, sodium iodohippuratedihydrate for.......................................................................... 1085

Radiopharmaceutical preparations, tetra-O-acetyl-mannosetriflate for .............................................................................. 1110

Raloxifene hydrochloride ...................................................... 3150Raman spectrometry (2.2.48.)................................................... 84Ramipril ................................................................................... 3152Ramon assay, flocculation value (Lf) of diphtheria and tetanustoxins and toxoids (2.7.27.) ................................................... 261

Ranitidine hydrochloride....................................................... 3154Rapeseed oil, refined .............................................................. 3155Reagents (4.) .............................................................................. 425Reagents (4.1.1.)........................................................................ 425Reagents, standard solutions, buffer solutions (4.1.) ........... 425Recombinant DNA technology, products of......................... 763Recommendations on dissolution testing (5.17.1.) .............. 727Recommendations on methods for dosage forms testing(5.17.) ....................................................................................... 727

Rectal capsules .......................................................................... 806Rectal foams .............................................................................. 807Rectal preparations................................................................... 806Rectal preparations, semi-solid............................................... 807Rectal solutions and suspensions, powders and tablets for.. 806Rectal solutions, emulsions and suspensions........................ 807Rectal tampons.......................................................................... 807Red poppy petals..................................................................... 1363Reference standards (5.12.) ..................................................... 699Refractive index (2.2.6.) ............................................................. 26Relationship between reaction of solution, approximate pHand colour of certain indicators (2.2.4.) ................................ 25

Relative density (2.2.5.) .............................................................. 25Repaglinide.............................................................................. 3156Reserpine ................................................................................. 3157Residual pertussis toxin and irreversibility of pertussis toxoid(2.6.33.) .................................................................................... 224

Residual solvents (5.4.) ............................................................ 639Residual solvents, identification and control (2.4.24.) ......... 141Residue on evaporation of essential oils (2.8.9.)................... 272Resistance to crushing of tablets (2.9.8.) ............................... 299Resorcinol ................................................................................ 3158Respiratory syncytial virus vaccine (live), bovine ................ 940Restharrow root ...................................................................... 1364Retroviridae-derived vectors for human use......................... 712Rhatany root............................................................................ 1365Rhatany tincture ..................................................................... 1365Rhinotracheitis vaccine (inactivated), viral, feline ............... 976Rhinotracheitis vaccine (live), bovine, infectious................. 983Rhinotracheitis vaccine (live), infectious, turkey ............... 1022Rhinotracheitis vaccine (live), viral, feline ............................ 977Rhubarb ................................................................................... 1366Ribavirin .................................................................................. 3159Riboflavin................................................................................. 3160Riboflavin sodium phosphate ............................................... 3162Ribose in polysaccharide vaccines (2.5.31.) .......................... 164Ribwort plantain ..................................................................... 1367Rice starch ............................................................................... 3163Rifabutin .................................................................................. 3164Rifampicin ............................................................................... 3165Rifamycin sodium................................................................... 3166Rifaximin ................................................................................. 3167Rilmenidine dihydrogen phosphate ..................................... 3169Risedronate sodium 2.5-hydrate........................................... 3170Risperidone ............................................................................. 3171Ritonavir .................................................................................. 3173Rivastigmine............................................................................ 3176Rivastigmine hydrogen tartrate ............................................ 3178Rizatriptan benzoate .............................................................. 3179Rocuronium bromide............................................................. 3181



Roman chamomile flower...................................................... 1206Ropivacaine hydrochloride monohydrate ........................... 3183Roselle ...................................................................................... 1368Rosemary leaf.......................................................................... 1369Rosemary oil ........................................................................... 1370Rotating viscometer method - viscosity (2.2.10.) ................... 28Rotation, optical (2.2.7.) ............................................................ 26Rotavirus diarrhoea vaccine (inactivated), calf .................... 944Rotavirus vaccine (live, oral)................................................... 898Roxithromycin ........................................................................ 3185RRR-α-Tocopherol.................................................................. 3437RRR-α-Tocopheryl acetate..................................................... 3439RRR-α-Tocopheryl hydrogen succinate ............................... 3443Rubber closures for containers for aqueous parenteralpreparations, for powders and for freeze-dried powders(3.2.9.) ...................................................................................... 421

Rubella immunoglobulin, human ........................................ 2432Rubella, measles and mumps vaccine (live) .......................... 872Rubella, measles, mumps and varicella vaccine (live).......... 873Rubella vaccine (live) ............................................................... 900Ruminant colibacillosis vaccine (inactivated), neonatal...... 994Rutoside trihydrate ................................................................. 3187

SSaccharin.................................................................................. 3191Saccharin sodium ................................................................... 3192Safety, viral (5.1.7.) ................................................................... 571Safflower flower ...................................................................... 1371Safflower oil, refined............................................................... 3193Saffron for homoeopathic preparations............................... 1455Sage leaf (salvia officinalis).................................................... 1373Sage leaf, three-lobed ............................................................. 1373Sage oil, Spanish...................................................................... 1389Sage tincture ............................................................................ 1374Salbutamol ............................................................................... 3193Salbutamol sulfate................................................................... 3195Salicylic acid ............................................................................ 3198Salmeterol xinafoate ............................................................... 3199Salmonella Enteritidis vaccine (inactivated) for chickens.. 1012Salmonella Enteritidis vaccine (live, oral) for chickens ..... 1013Salmonella Typhimurium vaccine (inactivated) forchickens ................................................................................. 1015

Salmonella Typhimurium vaccine (live, oral) forchickens ................................................................................. 1016

Salmon oil, farmed ................................................................. 3201Salvia miltiorrhiza root and rhizome................................... 1374Sanguisorba root..................................................................... 1376Saponification value (2.5.6.) .................................................... 157Saquinavir mesilate................................................................. 3202Saw palmetto extract .............................................................. 1377Saw palmetto fruit .................................................................. 1379Schisandra fruit....................................................................... 1381Scopolamine ............................................................................ 2461Scopolamine butylbromide ................................................... 2462Scopolamine hydrobromide .................................................. 2464Selamectin for veterinary use................................................ 3204Selegiline hydrochloride ........................................................ 3206Selenium disulfide .................................................................. 3207Selfheal fruit-spike, common ................................................ 1219Semi-micro determination of water (2.5.12.)........................ 158Semi-solid ear preparations..................................................... 782Semi-solid eye preparations .................................................... 784Semi-solid intrauterine preparations ..................................... 787Semi-solid nasal preparations ................................................. 793Semi-solid oromucosal preparations...................................... 794Semi-solid preparations for cutaneous application.............. 807Semi-solid rectal preparations ................................................ 807Semi-solid vaginal preparations ............................................. 813Senega root .............................................................................. 1382Senna leaf................................................................................. 1383Senna leaf dry extract, standardised .................................... 1384Senna pods, Alexandrian....................................................... 1384

Senna pods, Tinnevelly .......................................................... 1385Separation techniques, chromatographic (2.2.46.) ................. 72Serine........................................................................................ 3208Sertaconazole nitrate .............................................................. 3209Sertraline hydrochloride........................................................ 3210Sesame oil, refined.................................................................. 3212Sets for the transfusion of blood and blood components(3.2.6.) ...................................................................................... 418

Sevoflurane .............................................................................. 3214Shampoos .................................................................................. 790Shellac ..................................................................................... 3216Shingles (herpes zoster) vaccine (live) ................................... 902Sialic acid in polysaccharide vaccines (2.5.23.)..................... 161Siam benzoin tincture ............................................................ 1171Sieves (2.1.4.)............................................................................... 16Sieve test (2.9.12.) ..................................................................... 305Sieving, analytical, particle-size distribution estimation by(2.9.38.) .................................................................................... 351

Sieving, analytical, particle-size distribution estimation by(2.9.38.) (5.8.).......................................................................... 679

SI (International System) units (1.) ............................................ 3Sildenafil citrate ...................................................................... 3217Silica, colloidal anhydrous..................................................... 3218Silica, colloidal hydrated........................................................ 3219Silica, dental type.................................................................... 3219Silica, hydrophobic colloidal ................................................. 3220Silicate, aluminium magnesium............................................ 1521Silicate, aluminium sodium................................................... 1524silicone elastomer for closures and tubing (3.1.9.) ............... 394Silicone oil used as a lubricant (3.1.8.)................................... 393Silk suture, sterile, braided, in distributor for veterinary use................................................................................................ 1129

Silver, colloidal, for external use........................................... 3221Silver nitrate ............................................................................ 3221Simeticone ............................................................................... 3222Simvastatin .............................................................................. 3223Single-dose preparations, uniformity of content (2.9.6.)..... 298Single-dose preparations, uniformity of mass (2.9.5.) ......... 297Sintered-glass filters (2.1.2.) ...................................................... 15Size-exclusion chromatography (2.2.30.)................................. 46(S)-Lactic acid ......................................................................... 2579Smallpox vaccine (live) ............................................................ 903Sodium acetate ([1-11C]) injection........................................ 1078Sodium acetate trihydrate...................................................... 3224Sodium alendronate ............................................................... 3225Sodium alginate ...................................................................... 3226Sodium aluminium silicate.................................................... 1524Sodium amidotrizoate............................................................ 3227Sodium aminosalicylate dihydrate ....................................... 3228Sodium ascorbate ................................................................... 3229Sodium aurothiomalate ......................................................... 3230Sodium benzoate .................................................................... 3232Sodium bromide ..................................................................... 3232Sodium calcium edetate......................................................... 3233Sodium calcium pentetate for radiopharmaceuticalpreparations .......................................................................... 1075

Sodium caprylate .................................................................... 3234Sodium carbonate, anhydrous .............................................. 3235Sodium carbonate decahydrate............................................. 3236Sodium carbonate monohydrate .......................................... 3236Sodium carboxymethylcellulose ........................................... 1774Sodium carboxymethylcellulose, cross-linked.................... 1969Sodium carboxymethylcellulose, low-substituted .............. 1775Sodium cetostearyl sulfate..................................................... 3237Sodium chloride...................................................................... 3238Sodium chromate (51Cr) sterile solution.............................. 1079Sodium citrate ......................................................................... 3239Sodium cromoglicate ............................................................. 3240Sodium cyclamate................................................................... 3241Sodium dihydrogen phosphate dihydrate ........................... 3242Sodium disulfite ...................................................................... 3254Sodium ethyl parahydroxybenzoate..................................... 3243Sodium fluoride ...................................................................... 3244



Sodium fluoride (18F) injection............................................. 1079Sodium fusidate ...................................................................... 3245Sodium glycerophosphate, hydrated .................................... 3247Sodium hyaluronate ............................................................... 3248Sodium hydrogen carbonate ................................................. 3250Sodium hydroxide .................................................................. 3251Sodium iodide......................................................................... 3251Sodium iodide (123I) injection ............................................... 1080Sodium iodide (123I) solution for radiolabelling ................. 1081Sodium iodide (131I) capsules for diagnostic use ................ 1082Sodium iodide (131I) capsules for therapeutic use .............. 1083Sodium iodide (131I) solution ................................................ 1084Sodium iodide (131I) solution for radiolabelling ................. 1084Sodium iodohippurate (123I) injection ................................. 1086Sodium iodohippurate (131I) injection ................................. 1087Sodium iodohippurate dihydrate for radiopharmaceuticalpreparations .......................................................................... 1085

Sodium lactate solution ......................................................... 3252Sodium laurilsulfate ............................................................... 3254Sodium metabisulfite ............................................................. 3254Sodium methyl parahydroxybenzoate ................................. 3255Sodium molybdate (99Mo) solution (fission) ...................... 1088Sodium molybdate dihydrate ................................................ 3256Sodium nitrite ......................................................................... 3257Sodium nitroprusside............................................................. 3257Sodium perborate, hydrated.................................................. 3258Sodium pertechnetate (99mTc) injection (fission) ............... 1090Sodium pertechnetate (99mTc) injection (non-fission) ....... 1091Sodium phenylbutyrate.......................................................... 3258Sodium phosphate (32P) injection......................................... 1092Sodium picosulfate ................................................................. 3260Sodium polystyrene sulfonate ............................................... 3261Sodium propionate ................................................................. 3262Sodium propyl parahydroxybenzoate .................................. 3263Sodium risedronate 2.5-hydrate ........................................... 3170Sodium salicylate .................................................................... 3264Sodium selenite pentahydrate ............................................... 3264Sodium (S)-lactate solution................................................... 3253Sodium starch glycolate (type A).......................................... 3265Sodium starch glycolate (type B) .......................................... 3266Sodium starch glycolate (type C).......................................... 3267Sodium stearate....................................................................... 3267Sodium stearyl fumarate........................................................ 3268Sodium sulfate, anhydrous .................................................... 3269Sodium sulfate decahydrate................................................... 3270Sodium sulfite, anhydrous ..................................................... 3270Sodium sulfite heptahydrate.................................................. 3271Sodium tetrachloroaurate dihydrate for homoeopathicpreparations .......................................................................... 1455

Sodium thiosulfate.................................................................. 3271Sodium valproate.................................................................... 3272Soft capsules .............................................................................. 780Softening time determination of lipophilic suppositories(2.9.22.) .................................................................................... 323

Soft extracts ............................................................................... 746Solid dosage forms, dissolution test for (2.9.3.).................... 288Solid dosage forms, recommendations on dissolution testingof (5.17.1.)................................................................................ 727

Solids by mercury porosimetry, porosity and pore-sizedistribution of (2.9.32.) .......................................................... 336

Solids, density of (2.2.42.).......................................................... 68Solids, gas pycnometric density of (2.9.23.) .......................... 324Solids (porous) including powders, wettability of (2.9.45.).. 365Solubility in alcohol of essential oils (2.8.10.) ....................... 272Soluble tablets ........................................................................... 811Solution calorimetry and microcalorimetry, characterisationof crystalline solids by (2.2.61.) ............................................ 106

Solutions, emulsions and suspensions, oral .......................... 790Solutions for haemodialysis................................................... 2376Solutions for haemodialysis, concentrated, water fordiluting................................................................................... 2375

Solutions for haemofiltration and haemodiafiltration ....... 2378Solutions for organ preservation .......................................... 3273

Solutions for peritoneal dialysis............................................ 2994Solutions, suspensions, intrauterine....................................... 787Solvents, residual (5.4.) ............................................................ 639Solvents, residual, identification and control (2.4.24.)......... 141Somatostatin............................................................................ 3274Somatropin .............................................................................. 3275Somatropin concentrated solution ....................................... 3277Somatropin for injection ....................................................... 3279Sophora flower ........................................................................ 1386Sophora flower-bud................................................................ 1388Sorbic acid ............................................................................... 3281Sorbitan laurate....................................................................... 3282Sorbitan oleate......................................................................... 3282Sorbitan palmitate .................................................................. 3282Sorbitan sesquioleate.............................................................. 3283Sorbitan stearate ..................................................................... 3283Sorbitan trioleate .................................................................... 3284Sorbitol..................................................................................... 3284Sorbitol, liquid (crystallising) ............................................... 3286Sorbitol, liquid (non-crystallising) ....................................... 3286Sorbitol, liquid, partially dehydrated ................................... 3287Sotalol hydrochloride............................................................. 3288Soya-bean oil, hydrogenated ................................................. 3289Soya-bean oil, refined............................................................. 3290Spanish sage oil ....................................................................... 1389Specific surface area by air permeability (2.9.14.) ................ 305Specific surface area by gas adsorption (2.9.26.) .................. 329Specific surface area by gas adsorption (2.9.26.) (5.8.) ........ 679Spectinomycin dihydrochloride pentahydrate.................... 3290Spectinomycin sulfate tetrahydrate for veterinary use ...... 3292Spectrometry, atomic absorption (2.2.23.) .............................. 36Spectrometry, atomic emission (2.2.22.) ................................. 35Spectrometry, mass (2.2.43.) ..................................................... 69Spectrometry, nuclear magnetic resonance (2.2.33.) ............. 52Spectrometry, Raman (2.2.48.) ................................................. 84Spectrometry, X-ray fluorescence (2.2.37.) ............................. 59Spectrophotometry, infrared absorption (2.2.24.) ................. 38Spectrophotometry, ultraviolet and visible absorption(2.2.25.) ...................................................................................... 40

Spectroscopy, near-infrared (2.2.40.) ....................................... 62SPF chicken flocks for the production and quality control ofvaccines (5.2.2.)....................................................................... 579

Spheroids and granules, friability of (2.9.41.) ....................... 359Spike lavender oil.................................................................... 1390Spiramycin............................................................................... 3294Spirapril hydrochloride monohydrate ................................. 3296Spironolactone ........................................................................ 3298Spot-on preparations................................................................ 814Sprays (liquid nasal) and drops (nasal).................................. 792Sprays, veterinary ..................................................................... 814Squalane................................................................................... 3300Standard solutions for limit tests (4.1.2.)............................... 536Standards, reference (5.12.) ..................................................... 699Stannous chloride dihydrate.................................................. 3302Stanozolol ................................................................................ 3302Star anise.................................................................................. 1394Star anise oil ............................................................................ 1395Starches, hydroxyethyl ........................................................... 3307Starch glycolate (type A), sodium......................................... 3265Starch glycolate (type B), sodium......................................... 3266Starch glycolate (type C), sodium......................................... 3267Starch, hydroxypropyl ............................................................ 3303Starch, hydroxypropyl, pregelatinised.................................. 3305Starch, maize ........................................................................... 2684Starch, maize(5.8.) .................................................................... 677Starch, potato .......................................................................... 3078Starch, potato (5.8.) .................................................................. 677Starch, pregelatinised ............................................................. 3306Starch, rice ............................................................................... 3163Starch, wheat ........................................................................... 3563Starch, wheat (5.8.) ................................................................... 677Starflower (borage) oil, refined ............................................. 1681



Statistical analysis of results of biological assays and tests(5.3.) ......................................................................................... 607

Stavudine ................................................................................. 3311Steam sterilisation of aqueous preparations, application of theF0 concept (5.1.5.) ................................................................... 560

Stearic acid............................................................................... 3313Stearoyl macrogolglycerides .................................................. 3314Stearyl alcohol ......................................................................... 3314Stem cells, human haematopoietic ....................................... 2419Stephania root, fourstamen ................................................... 1246Sterile braided silk suture in distributor for veterinaryuse........................................................................................... 1129

Sterile catgut ............................................................................ 1117Sterile catgut in distributor for veterinary use.................... 1127Sterile containers of plasticised poly(vinyl chloride) for humanblood containing anticoagulant solution (3.2.5.) ............... 418

Sterile linen thread in distributor for veterinary use ......... 1128Sterile non-absorbable strands in distributor for veterinaryuse........................................................................................... 1129

Sterile non-absorbable sutures .............................................. 1118Sterile plastic containers for human blood and bloodcomponents (3.2.3.)................................................................ 415

Sterile polyamide 6/6 suture in distributor for veterinaryuse........................................................................................... 1128

Sterile polyamide 6 suture in distributor for veterinaryuse........................................................................................... 1128

Sterile poly(ethylene terephthalate) suture in distributor forveterinary use........................................................................ 1129

Sterile products, methods of preparation (5.1.1.)................. 555Sterile single-use plastic syringes (3.2.8.) .............................. 419Sterile synthetic absorbable braided sutures ....................... 1122Sterile synthetic absorbable monofilament sutures ............ 1123Sterilisation procedures, biological indicators (5.1.2.)......... 556Sterility (2.6.1.).......................................................................... 175Sterility (2.6.1.) (5.8.) ............................................................... 678Sterility, guidelines for using the test for (5.1.9.).................. 572Sterols in fatty oils (2.4.23.) ..................................................... 139Sticks .......................................................................................... 809Sticks, intrauterine.................................................................... 787Sticks, nasal ............................................................................... 793St. John’s wort.......................................................................... 1391St. John’s wort dry extract, quantified.................................. 1393Stomata and stomatal index (2.8.3.) ....................................... 271Stramonium leaf ..................................................................... 1397Stramonium, prepared ........................................................... 1399Strands, sterile non-absorbable, in distributor for veterinaryuse .......................................................................................... 1129

Streptokinase concentrated solution .................................... 3315Streptomycin sulfate ............................................................... 3317Strontium (89Sr) chloride injection....................................... 1092Subdivision of tablets ............................................................... 809Sublingual sprays, oromucosal drops and oromucosalsprays........................................................................................ 793

Sublingual tablets and buccal tablets...................................... 795Substances for pharmaceutical use......................................... 765Substances for pharmaceutical use, control of impurities in(5.10.) ....................................................................................... 689

Substances of animal origin for the production ofimmunological veterinary medicinal products (5.2.5.) ..... 587

Sub-visible particles, particulate contamination (2.9.19.) ... 321Sub-visible particles, particulate contamination (2.9.19.)(5.8.) ......................................................................................... 679

Sucralfate ................................................................................. 3318Sucralose .................................................................................. 3319Sucrose ..................................................................................... 3321Sucrose monopalmitate.......................................................... 3322Sucrose stearate....................................................................... 3323Sufentanil ................................................................................. 3325Sufentanil citrate ..................................................................... 3326Sugars, lead in (2.4.10.) ............................................................ 131Sugar spheres........................................................................... 3327Sulbactam sodium .................................................................. 3328Sulfacetamide sodium............................................................ 3330

Sulfadiazine ............................................................................. 3331Sulfadimidine .......................................................................... 3332Sulfadoxine .............................................................................. 3334Sulfafurazole............................................................................ 3334Sulfaguanidine ........................................................................ 3335Sulfamerazine.......................................................................... 3336Sulfamethizole......................................................................... 3337Sulfamethoxazole.................................................................... 3338Sulfamethoxypyridazine for veterinary use......................... 3339Sulfanilamide........................................................................... 3340Sulfasalazine ............................................................................ 3340Sulfated ash (2.4.14.) ................................................................ 132Sulfated ash (2.4.14.) (5.8.)...................................................... 678Sulfates (2.4.13.)........................................................................ 132Sulfathiazole ............................................................................ 3342Sulfinpyrazone......................................................................... 3343Sulfur dioxide (2.5.29.)............................................................. 164Sulfur for external use............................................................ 3344Sulfur for homoeopathic preparations................................. 1456Sulfuric acid............................................................................. 3345Sulindac.................................................................................... 3345Sulpiride................................................................................... 3346Sultamicillin ............................................................................ 3348Sultamicillin tosilate dihydrate ............................................. 3350Sumatra benzoin..................................................................... 1170Sumatra benzoin tincture ...................................................... 1172Sumatriptan succinate............................................................ 3352Sunflower oil, refined ............................................................. 3354Supercritical fluid chromatography (2.2.45.) .......................... 72Suppositories ............................................................................. 806Suppositories and pessaries, disintegration of (2.9.2.) ......... 287Suppositories, lipophilic, softening time determination(2.9.22.) .................................................................................... 323

Suspensions, solutions and emulsions, oral .......................... 790Suspensions, solutions, intrauterine....................................... 787Sutures, sterile non-absorbable ............................................. 1118Sutures, sterile synthetic absorbable braided ..................... 1122Sutures, sterile synthetic absorbable monofilament .......... 1123Suxamethonium chloride ...................................................... 3354Suxibuzone .............................................................................. 3355Sweet fennel............................................................................. 1242Sweet orange oil ...................................................................... 1400Swelling index (2.8.4.) .............................................................. 271Swine erysipelas vaccine (inactivated) ................................. 1018Swine-fever vaccine (live, prepared in cell cultures),classical .................................................................................. 1019

Symbols and abbreviations (1.) ................................................... 3Synthetic absorbable braided sutures, sterile ...................... 1122Synthetic absorbable monofilament sutures, sterile ........... 1123Syringes, plastic, sterile single-use (3.2.8.) ............................ 419Syrups......................................................................................... 791

TTable of physical characteristics of radionuclides mentioned inthe European Pharmacopoeia (5.7.)..................................... 667

Tablets ........................................................................................ 809Tablets and capsules, disintegration of (2.9.1.) ..................... 285Tablets and capsules, disintegration of (2.9.1.) (5.8.)........... 678Tablets and powders for rectal solutions and suspensions .. 807Tablets, buccal ........................................................................... 795Tablets, chewable ...................................................................... 811Tablets, coated........................................................................... 810Tablets, dispersible.................................................................... 811Tablets, effervescent.................................................................. 811Tablets for intrauterine solutions and suspensions .............. 787Tablets for use in the mouth.................................................... 812Tablets for vaginal solutions and suspensions ...................... 813Tablets, gastro-resistant............................................................ 811Tablets, intrauterine.................................................................. 787Tablets, modified-release ......................................................... 811Tablets, orodispersible.............................................................. 811Tablets, resistance to crushing (2.9.8.) ................................... 299



Tablets, soluble .......................................................................... 811Tablets, subdivision of.............................................................. 809Tablets, sublingual .................................................................... 795Tablets, uncoated ...................................................................... 810Tablets, uncoated, friability of (2.9.7.) ................................... 298Tablets, uncoated, friability of (2.9.7.) (5.8.) ......................... 678Tablets, vaginal.......................................................................... 813Tadalafil.................................................................................... 3359Talc ........................................................................................... 3361Tamoxifen citrate .................................................................... 3363Tampons, ear ............................................................................. 782Tampons, medicated ............................................................... 812Tampons, rectal......................................................................... 807Tampons, vaginal, medicated.................................................. 814Tamsulosin hydrochloride..................................................... 3364Tannic acid .............................................................................. 3366Tannins in herbal drugs (2.8.14.)............................................ 275Tapped density and bulk density of powders (2.9.34.)......... 343Tartaric acid............................................................................. 3367Teat dips ..................................................................................... 814Tea tree oil ............................................................................... 1401Teat sprays ................................................................................. 814Technetium (99mTc) bicisate injection .................................. 1093Technetium (99mTc) colloidal rhenium sulfide injection ... 1094Technetium (99mTc) colloidal sulfur injection ..................... 1095Technetium (99mTc) colloidal tin injection .......................... 1095Technetium (99mTc) etifenin injection.................................. 1096Technetium (99mTc) exametazime injection ........................ 1097Technetium (99mTc) gluconate injection .............................. 1098Technetium (99mTc) human albumin injection ................... 1099Technetium (99mTc) macrosalb injection ............................. 1100Technetium (99mTc) mebrofenin injection ........................... 1101Technetium (99mTc) medronate injection ............................ 1102Technetium (99mTc) mertiatide injection ............................. 1104Technetium (99mTc) microspheres injection ........................ 1105Technetium (99mTc) pentetate injection ............................... 1106Technetium (99mTc) sestamibi injection............................... 1107Technetium (99mTc) succimer injection................................ 1108Technetium (99mTc) tin pyrophosphate injection ............... 1109Teicoplanin .............................................................................. 3367Telmisartan.............................................................................. 3369Temazepam.............................................................................. 3371Tenosynovitis vaccine (live), viral, avian ............................... 935Tenoxicam ............................................................................... 3372Terazosin hydrochloride dihydrate ...................................... 3373Terbinafine hydrochloride ..................................................... 3375Terbutaline sulfate .................................................................. 3377Terconazole.............................................................................. 3378Terfenadine.............................................................................. 3379Terminology used in monographs on biological products(5.2.1.) ...................................................................................... 579

Test for anticomplementary activity of immunoglobulin(2.6.17.) .................................................................................... 200

Test for anti-D antibodies in human immunoglobulin(2.6.26.) .................................................................................... 215

Test for aristolochic acids in herbal drugs (2.8.21) .............. 279Test for extractable volume of parenteral preparations(2.9.17.) .................................................................................... 308

Test for extractable volume of parenteral preparations (2.9.17.)(5.8.) ......................................................................................... 679

Test for Fc function of immunoglobulin (2.7.9.) .................. 246Test for methanol and 2-propanol (2.9.11.) .......................... 304Test for neurovirulence of live virus vaccines (2.6.18.)........ 202Test for neurovirulence of poliomyelitis vaccine (oral)(2.6.19.) .................................................................................... 202

Test for specified micro-organisms (microbiologicalexamination of non-sterile products) (2.6.13.) ................... 189

Test for specified micro-organisms (microbiologicalexamination of non-sterile products) (2.6.13.) (5.8.) ........ 678

Testosterone............................................................................. 3380Testosterone decanoate .......................................................... 3382Testosterone enantate ............................................................. 3383Testosterone isocaproate ........................................................ 3385

Testosterone propionate......................................................... 3386Tests for extraneous agents in viral vaccines for human use(2.6.16.) .................................................................................... 198

Tetanus and diphtheria toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.)............................................ 261

Tetanus and diphtheria vaccine (adsorbed) .......................... 823Tetanus and diphtheria vaccine (adsorbed, reduced antigen(s)content).................................................................................... 824

Tetanus antitoxin for human use .......................................... 1033Tetanus antitoxin for veterinary use..................................... 1040Tetanus, diphtheria and hepatitis B (rDNA) vaccine(adsorbed) ............................................................................... 825

Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed) ................................................................. 826

Tetanus, diphtheria and pertussis (whole cell) vaccine(adsorbed) ............................................................................... 827

Tetanus, diphtheria and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content)............................... 829

Tetanus, diphtheria, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ............ 830

Tetanus, diphtheria, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ............................... 832

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed)................... 834

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) ................................................................. 835

Tetanus, diphtheria, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ............ 837

Tetanus, diphtheria, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed) ................................................................. 840

Tetanus, diphtheria, pertussis (whole cell) and poliomyelitis(inactivated) vaccine (adsorbed) .......................................... 842

Tetanus, diphtheria, pertussis (whole cell), poliomyelitis(inactivated) and haemophilus type b conjugate vaccine(adsorbed) ............................................................................... 844

Tetanus immunoglobulin, human ........................................ 2432Tetanus vaccine (adsorbed) ..................................................... 907Tetanus vaccine (adsorbed), assay of (2.7.8.) ........................ 242Tetanus vaccine for veterinary use ....................................... 1021Tetracaine hydrochloride....................................................... 3387Tetracosactide.......................................................................... 3388Tetracycline ............................................................................. 3390Tetracycline hydrochloride.................................................... 3391Tetra-O-acetyl-mannose triflate for radiopharmaceuticalpreparations .......................................................................... 1110

Tetrazepam .............................................................................. 3393Tetryzoline hydrochloride ..................................................... 3394Thallous (201Tl) chloride injection ........................................ 1111Theobromine........................................................................... 3395Theophylline ........................................................................... 3395Theophylline-ethylenediamine, anhydrous......................... 3398Theophylline-ethylenediamine hydrate ............................... 3399Theophylline monohydrate ................................................... 3396Thermal analysis (2.2.34.).......................................................... 55Thermogravimetry (2.2.34.) ...................................................... 55Thiamazole .............................................................................. 3401Thiamine hydrochloride ........................................................ 3402Thiamine nitrate ..................................................................... 3403Thiamphenicol ........................................................................ 3405Thin-layer chromatography (2.2.27.) ....................................... 42Thioctic acid............................................................................ 3405Thiomersal............................................................................... 3406Thiopental sodium and sodium carbonate ......................... 3407Thioridazine ............................................................................ 3409Thioridazine hydrochloride .................................................. 3410Thomson kudzuvine root ...................................................... 1402Three-lobed sage leaf ............................................................. 1373Threonine ................................................................................ 3411Thyme ...................................................................................... 1403Thyme oil, thymol type.......................................................... 1405



Thyme, wild............................................................................. 1421Thymol..................................................................................... 3412Thymol type thyme oil........................................................... 1405Tiabendazole ........................................................................... 3413Tiamulin for veterinary use................................................... 3414Tiamulin hydrogen fumarate for veterinary use................. 3416Tianeptine sodium.................................................................. 3418Tiapride hydrochloride .......................................................... 3419Tiaprofenic acid ...................................................................... 3420Tibolone................................................................................... 3421Ticarcillin sodium .................................................................. 3423Tick-borne encephalitis vaccine (inactivated) ...................... 908Ticlopidine hydrochloride ..................................................... 3424Tilidine hydrochloride hemihydrate .................................... 3426Timolol maleate ...................................................................... 3427Tinctures .................................................................................... 745Tinidazole ................................................................................ 3429Tinnevelly senna pods............................................................ 1385Tinzaparin sodium ................................................................. 3430Tioconazole ............................................................................. 3430Tiotropium bromide monohydrate ...................................... 3431Titanium dioxide .................................................................... 3433Titration, amperometric (2.2.19.) ............................................. 34Titration, potentiometric (2.2.20.)............................................ 34Titrations, complexometric (2.5.11.)...................................... 158Titration, voltametric (2.2.65.)................................................ 109Tobramycin.............................................................................. 3434Tocopherol, all-rac-α-............................................................. 3436Tocopherol, RRR-α-................................................................ 3437Tocopheryl acetate, all-rac-α- ............................................... 3438α-Tocopheryl acetate concentrate (powder form) .............. 3441Tocopheryl acetate, RRR-α-................................................... 3439Tocopheryl hydrogen succinate, DL-α- ................................ 3442Tocopheryl hydrogen succinate, RRR-α- ............................. 3443Tolbutamide............................................................................. 3445Tolfenamic acid....................................................................... 3446Tolnaftate ................................................................................. 3447Tolu balsam ............................................................................. 1406Torasemide, anhydrous .......................................................... 3449Tormentil ................................................................................. 1407Tormentil tincture .................................................................. 1407Tosylchloramide sodium ....................................................... 3450Total ash (2.4.16.)...................................................................... 132Total cholesterol in oils rich in omega-3 acids (2.4.32.) ...... 151Total organic carbon in water for pharmaceutical use(2.2.44.) ...................................................................................... 71

Total protein (2.5.33.)............................................................... 165Toxicity, abnormal (2.6.9.)....................................................... 184Tragacanth ............................................................................... 1408Tramadol hydrochloride ........................................................ 3450Tramazoline hydrochloride monohydrate........................... 3452Trandolapril............................................................................. 3453Tranexamic acid...................................................................... 3454Transdermal patches ................................................................ 798Transdermal patches, dissolution test for (2.9.4.)................. 295Trapidil..................................................................................... 3455Trehalose dihydrate ................................................................ 3456Tretinoin .................................................................................. 3458Triacetin ................................................................................... 3459Triamcinolone ......................................................................... 3459Triamcinolone acetonide ....................................................... 3460Triamcinolone hexacetonide ................................................. 3462Triamterene ............................................................................. 3463Tribenoside.............................................................................. 3465Tributyl acetylcitrate............................................................... 3466Trichloroacetic acid ................................................................ 3468Triethanolamine...................................................................... 3481Triethyl citrate ......................................................................... 3468Trifluoperazine hydrochloride .............................................. 3469Triflusal .................................................................................... 3470Triglycerides, medium-chain ................................................ 3471Triglycerides, omega-3-acid .................................................. 2909Triglycerol diisostearate ......................................................... 3472

Trihexyphenidyl hydrochloride ............................................ 3473Trimebutine maleate .............................................................. 3474Trimeprazine hemitartrate .................................................... 1504Trimetazidine dihydrochloride ............................................. 3475Trimethadione......................................................................... 3476Trimethoprim.......................................................................... 3477Trimipramine maleate............................................................ 3479Tri-n-butyl phosphate ............................................................ 3467Tritiated (3H) water injection ................................................ 1111Trolamine................................................................................. 3481Trometamol ............................................................................. 3483Tropicamide............................................................................. 3483Tropisetron hydrochloride..................................................... 3485Trospium chloride .................................................................. 3486Troxerutin................................................................................ 3488Trypsin ..................................................................................... 3489Tryptophan .............................................................................. 3490TSE, animal, minimising the risk of transmitting via humanand veterinary medicinal products (5.2.8.) ......................... 592

TSE, animal, products with risk of transmitting agents of.. 759Tuberculin for human use, old.............................................. 3492Tuberculin purified protein derivative, avian ..................... 3493Tuberculin purified protein derivative, bovine ................... 3494Tuberculin purified protein derivative for human use....... 3495Tuberculosis (BCG) vaccine, freeze-dried............................. 819Tubes for comparative tests (2.1.5.).......................................... 17Tubing and closures, silicone elastomer for (3.1.9.) ............. 394Tubing and containers for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.)..... 391

Tubing used in sets for the transfusion of blood and bloodcomponents, materials based on plasticised poly(vinylchloride) for (3.1.1.2.) ............................................................ 378

Turkey infectious rhinotracheitis vaccine (live) ................. 1022Turmeric, Javanese.................................................................. 1409Turmeric rhizome................................................................... 1410Turpentine oil, Pinus pinaster type ...................................... 1411Tylosin for veterinary use ...................................................... 3497Tylosin phosphate bulk solution for veterinary use ........... 3498Tylosin tartrate for veterinary use ........................................ 3500Typhoid polysaccharide and hepatitis A (inactivated,adsorbed) vaccine ................................................................... 851

Typhoid polysaccharide vaccine ............................................. 910Typhoid vaccine ........................................................................ 911Typhoid vaccine, freeze-dried ................................................. 911Typhoid vaccine (live, oral, strain Ty 21a) ............................ 912Tyrosine ................................................................................... 3501Tyrothricin............................................................................... 3502

UUbidecarenone ........................................................................ 3507Udder-washes............................................................................ 814Ultraviolet and visible absorption spectrophotometry(2.2.25.) ...................................................................................... 40

Ultraviolet ray lamps for analytical purposes (2.1.3.) ............ 15Uncoated tablets ....................................................................... 810Undecylenic acid..................................................................... 3508Uniformity of content of single-dose preparations (2.9.6.).. 298Uniformity of dosage units (2.9.40.) ...................................... 357Uniformity of dosage units, demonstration using large samplesizes (2.9.47.) ........................................................................... 368

Uniformity of mass of delivered doses from multidosecontainers (2.9.27.) ................................................................. 331

Uniformity of mass of single-dose preparations (2.9.5.) ..... 297Units of the International System (SI) used in thePharmacopoeia and equivalence with other units (1.) .......... 3

Unsaponifiable matter (2.5.7.)................................................. 157Urea .......................................................................................... 3508Urofollitropin .......................................................................... 3509Urokinase................................................................................. 3510Uronic acids in polysaccharide vaccines (2.5.22.) ................ 161Ursodeoxycholic acid ............................................................ 3512



VVaccines, adsorbed, aluminium in (2.5.13.) .......................... 159Vaccines, adsorbed, calcium in (2.5.14.)................................ 159Vaccines and immunosera, phenol in (2.5.15.)..................... 159Vaccines and immunosera, veterinary, evaluation of efficacyof (5.2.7.).................................................................................. 591

Vaccines and immunosera, veterinary, evaluation of safety(5.2.6.) ...................................................................................... 588

Vaccines for human use ........................................................... 767Vaccines for human use, cell substrates for the production of(5.2.3.) ...................................................................................... 582

Vaccines for human use, viral, tests for extraneous agents in(2.6.16.) .................................................................................... 198

Vaccines for veterinary use...................................................... 770Vaccines, polysaccharide, hexosamines in (2.5.20.) ............. 160Vaccines, polysaccharide, methylpentoses in (2.5.21.)......... 161Vaccines, polysaccharide, nucleic acids in (2.5.17.) ............. 160Vaccines, polysaccharide, O-acetyl in (2.5.19.) ..................... 160Vaccines, polysaccharide, phosphorus in (2.5.18.) ............... 160Vaccines, polysaccharide, protein in (2.5.16.) ....................... 159Vaccines, polysaccharide, ribose in (2.5.31.)......................... 164Vaccines, polysaccharide, sialic acid in (2.5.23.) .................. 161Vaccines, polysaccharide, uronic acids in (2.5.22.) .............. 161Vaccines, SPF chicken flocks for the production and qualitycontrol of (5.2.2.) ................................................................... 579

Vaccines, veterinary, cell cultures for the production of(5.2.4.) ...................................................................................... 585

Vaccines, viral live, test for neurovirulence (2.6.18.) ........... 202Vaginal capsules ........................................................................ 813Vaginal foams............................................................................ 813Vaginal preparations ................................................................ 812Vaginal preparations, semi-solid ............................................ 813Vaginal solutions and suspensions, tablets for...................... 813Vaginal solutions, emulsions and suspensions...................... 813Vaginal tablets ........................................................................... 813Vaginal tampons, medicated ................................................... 814Valaciclovir hydrochloride, anhydrous ................................ 3517Valerian dry aqueous extract ............................................... 1412Valerian dry hydroalcoholic extract ..................................... 1413Valerian root............................................................................ 1413Valerian root, cut .................................................................... 1415Valerian tincture ..................................................................... 1416Validation of nucleic acid amplification techniques for thedetection of B19 virus (B19V) DNA in plasma pools :guidelines................................................................................. 204

Validation of nucleic acid amplification techniques for thedetection of hepatitis C virus (HCV) RNA in plasma pools :guidelines................................................................................. 204

Valine ....................................................................................... 3520Valnemulin hydrochloride for veterinary use .................... 3521Valproate, sodium................................................................... 3272Valproic acid............................................................................ 3523Valsartan .................................................................................. 3524Vancomycin hydrochloride ................................................... 3525Vanillin..................................................................................... 3527Vapour, preparations to be converted into............................ 801Varicella immunoglobulin for intravenous administration,human .................................................................................... 2434

Varicella immunoglobulin, human ...................................... 2434Varicella, measles, mumps and rubella vaccine (live) .......... 873Varicella vaccine (live) ............................................................. 913Vectors for human use, adenovirus ........................................ 708Vectors for human use, plasmid ............................................. 706Vectors for human use, plasmid, bacterial cells used for themanufacture of........................................................................ 707

Vectors for human use, poxvirus ............................................ 710Vecuronium bromide ............................................................. 3528Vedaprofen for veterinary use............................................... 3529Vegetable fatty oils .................................................................... 775Venlafaxine hydrochloride .................................................... 3530Verapamil hydrochloride ....................................................... 3532Verbena herb ........................................................................... 1417

Veterinary liquid preparations for cutaneous application... 814Veterinary medicinal products, immunological, substances ofanimal origin for the production of (5.2.5.)........................ 587

Veterinary vaccines and immunosera, evaluation of efficacy of(5.2.7.) ...................................................................................... 591

Viability, nucleated cell count and (2.7.29.) .......................... 263Vibriosis (cold-water) vaccine (inactivated) forsalmonids............................................................................... 1023

Vibriosis vaccine (inactivated) for salmonids ..................... 1024VICH (5.8.)................................................................................ 677Vigabatrin ................................................................................ 3534Vinblastine sulfate .................................................................. 3535Vincristine sulfate ................................................................... 3536Vindesine sulfate..................................................................... 3537Vinorelbine tartrate ................................................................ 3539Vinpocetine ............................................................................. 3541Viper venom antiserum, European ...................................... 1033Viral diarrhoea vaccine (inactivated), bovine ....................... 941Viral hepatitis type I vaccine (live), duck .............................. 964Viral rhinotracheitis vaccine (inactivated), feline ................ 976Viral rhinotracheitis vaccine (live), feline ............................. 977Viral safety (5.1.7.).................................................................... 571Viral tenosynovitis vaccine (live), avian ................................ 935Viral vaccines for human use, tests for extraneous agents in(2.6.16.) .................................................................................... 198

Viscometer method, capillary (2.2.9.) ...................................... 27Viscometer method, falling ball (2.2.49.) ................................ 85Viscose wadding, absorbent .................................................. 3542Viscosity (2.2.8.).......................................................................... 27Viscosity - rotating viscometer method (2.2.10.) ................... 28Visible and ultraviolet absorption spectrophotometry(2.2.25.) ...................................................................................... 40

Visible particles, particulate contamination (2.9.20.) .......... 323Vitamin A ................................................................................ 3544Vitamin A concentrate (oily form), synthetic ..................... 3545Vitamin A concentrate (powder form), synthetic .............. 3546VitaminA concentrate (solubilisate/emulsion), synthetic.. 3547Voltametric titration (2.2.65.) ................................................. 109Volumetric analysis (4.2.) ........................................................ 545Volumetric solutions (4.2.2.) ................................................... 546Volumetric solutions, primary standards for (4.2.1.)........... 545von Willebrand factor, human.............................................. 2435von Willebrand factor, human, assay of (2.7.21.) ................. 257Voriconazole............................................................................ 3548

WWarfarin sodium..................................................................... 3553Warfarin sodium clathrate..................................................... 3554Washes, nasal............................................................................. 793Water (15O) injection .............................................................. 1112Water, determination by distillation (2.2.13.) ......................... 31Water for diluting concentrated haemodialysis solutions.. 2375Water for injections ................................................................ 3555Water for pharmaceutical use, total organic carbon in(2.2.44.) ...................................................................................... 71

Water for preparation of extracts.......................................... 3558Water, highly purified ............................................................ 3559Water in essential oils (2.8.5.) ................................................. 271Water in gases (2.5.28.) ............................................................ 163Water : micro determination (2.5.32.) .................................... 164Water, purified ........................................................................ 3561Water : semi-micro determination (2.5.12.) .......................... 158Water-solid interactions: determination of sorption-desorption isotherms and of water activity (2.9.39) .......... 353

Wettability of porous solids including powders (2.9.45.) .... 365Wheat-germ oil, refined......................................................... 3563Wheat-germ oil, virgin........................................................... 3564Wheat starch............................................................................ 3563Wheat starch (5.8.) ................................................................... 677White beeswax ........................................................................ 1630White horehound ................................................................... 1419White soft paraffin.................................................................. 2966



Wild pansy (flowering aerial parts)...................................... 1420Wild thyme.............................................................................. 1421Willow bark ............................................................................. 1422Willow bark dry extract ......................................................... 1423Wool alcohols .......................................................................... 3564Wool fat.................................................................................... 3565Wool fat, hydrogenated.......................................................... 3569Wool fat, hydrous.................................................................... 3570Wormwood.............................................................................. 1424

XXanthan gum........................................................................... 3575Xenon (133Xe) injection .......................................................... 1113X-ray fluorescence spectrometry (2.2.37.)............................... 59X-ray powder diffraction (XRPD), characterisation ofcrystalline and partially crystalline solids by (2.9.33.)....... 339

Xylazine hydrochloride for veterinary use .......................... 3576Xylitol ....................................................................................... 3577Xylometazoline hydrochloride.............................................. 3579Xylose ....................................................................................... 3580

YYarrow ...................................................................................... 1425

Yellow beeswax........................................................................ 1630Yellow fever vaccine (live) ....................................................... 914Yellow soft paraffin................................................................. 2967Yersiniosis vaccine (inactivated) for salmonids .................. 1025Yohimbine hydrochloride ...................................................... 3585

ZZidovudine .............................................................................. 3589Zinc acetate dihydrate ............................................................ 3590Zinc acexamate ....................................................................... 3591Zinc chloride ........................................................................... 3592Zinc gluconate......................................................................... 3593Zinc oxide ................................................................................ 3594Zinc stearate ............................................................................ 3594Zinc sulfate heptahydrate ...................................................... 3595Zinc sulfate hexahydrate ........................................................ 3595Zinc sulfate monohydrate...................................................... 3595Zinc undecylenate .................................................................. 3596Ziprasidone hydrochloride monohydrate............................ 3596Zolpidem tartrate.................................................................... 3598Zopiclone ................................................................................. 3600Zoster (shingles) vaccine (live), herpes.................................. 902Zuclopenthixol decanoate...................................................... 3601




Documents

EUROPEANPHARMACOPOEIA8.0 INDEX - EDQM · EUROPEANPHARMACOPOEIA8.0 3604 See the information section on general monographs (cover pages)