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Not appropriate for regulatory submission. Please visit www.spectrumchemical.com or contact Tech Services for the most up‐to‐date information contained in this information package. Spectrum Chemical Mfg Corp 769 Jersey Avenue New Brunswick, NJ 08901 Phone 732.214.1300
Ver4.04 26.July.2019
Scientific Documentation PO185, Potassium Iodide, USP
Dear Customer,
Thank you for your interest in Spectrum’s quality products and services.
Spectrum has been proudly serving the scientific community for over 45 years. It is our mission to manufacture and distribute fine chemicals and laboratory products with Quality and delivery you can count on every time.
To accomplish our mission, Spectrum utilizes our sourcing leverage and supplier qualification expertise in offering one of the industry’s most comprehensive line of fine chemical products under one brand, in packaging configurations designed to meet your research and production requirements. Our product grades include: USP, NF, BP, EP, JP, FCC, ACS, KSA, Reagent grade, as well as DEA controlled substances. We operate facilities in the United States on the East Coast, West Coast, as well as in Shanghai, China in order to provide the best logistical support for our customers.
At Spectrum, Quality is priority number one. Suppliers with the best qualifications are preferred and we employ full-functioning in-house analytical laboratories at each of our facilities. Our facilities and systems are USFDA registered and ISO certified. We frequently host customer audits and cherish opportunities for improvements. Quality is engrained into our culture. Quality is priority number one.
In the following pages, we have designed and prepared documented scientific information to aid you in your initial qualification or your continual use of our products. Please do not hesitate to contact us if further information or the most up-to-date documentation is desired from any of the covered areas.
We appreciate your business and we look forward to hearing from you.
Sincerely,
Michael Dang Director, Quality Systems & GMP Compliance [email protected]
26.July.2019
PO185, Methylcellulose, Potassium Iodide, USP
Table of Contents
Product Specification
Safety Data Sheet (SDS)
Certification of Quality Management System (QMS)
Certification of current Good Manufacturing Practices (cGMP)
Product BSE/TSE Statement
Product Allergen Statement
Product Aflatoxin Statement
Product Certificate of Analysis Sample(s)
General Label Information – Sample Label
General Lot Numbering System Guidance
Stability – Shelf Life Guidance
Kosher Certificate
Halal Certificate
Specification for Potassium Iodide, USP (PO185)
Item Number PO185
Item Potassium Iodide, USP
CAS Number 7681-11-0
Molecular Formula KI
Molecular Weight 166.00
MDL Number
Synonyms
Test SpecificationMin Max
ASSAY 99.0 101.5 %
ALKALINITY NO COLOR IS PRODUCED
LOSS ON DRYING 1.0 %
IODATE 4 μg/g
NITRATE, NITRITE, AND AMMONIANO BLUE COLORATION OF
THE PAPER ISDISCERNIBLE
THIOSULFATE, BARIUM NO TURBIDITY DEVELOPSWITHIN 1 MIN.
ELEMENTAL IMPURITIES AS REPORTED
IDENTIFICATION (A) POSITIVE FOR POTASSIUM
IDENTIFICATION (B) POSITIVE FOR IODIDE
CERTIFIED KOSHER
CERTIFIED HALAL
RETEST DATE
DATE OF MANUFACTURE
APPEARANCE
RESIDUAL SOLVENTS AS REPORTED
https://www.spectrumchemical.comhttps://www.spectrumchemical.com/OA_HTML/chemical-products_Potassium-Iodide-USP_PO185.jsp?minisite=10020&respid=22372https://www.spectrumchemical.com/OA_HTML/chemical-products_Potassium-Iodide-USP_PO185.jsp?minisite=10020&respid=22372https://www.spectrumchemical.com/OA_HTML/chemical-cas_Potassium-Iodide-USP_7681-11-0.jsp?pCasName=Potassium-Iodide-USP
SAFETY DATA SHEETPreparation Date: 01/22/2015 Revision Date: 08/06/2018 Revision Number: G2
1. IDENTIFICATIONProduct identifier
Product code: PO185Product Name: POTASSIUM IODIDE, USP
Other means of identification Synonyms: No information availableCAS #: 7681-11-0RTECS # TT2975000CI#: Not available
Recommended use of the chemical and restrictions on use Recommended use: No information available.Uses advised against No information available
Supplier: Spectrum Chemical Mfg. Corp14422 South San Pedro St.Gardena, CA 90248(310) 516-8000
Order Online At: https://www.spectrumchemical.com Emergency telephone number Chemtrec 1-800-424-9300Contact Person: Martin LaBenz (West Coast)Contact Person: Ibad Tirmiz (East Coast)
2. HAZARDS IDENTIFICATION
Classification
This chemical is considered hazardous according to the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200)
Considered a dangerous substance or mixture according to the Globally Harmonized System (GHS)
Serious eye damage/eye irritation Category 2BSkin sensitization Category 1BReproductive toxicity Category 2Specific target organ toxicity (single exposure) Category 3Specific target organ toxicity (repeated exposure) Category 1
Label elements
Danger
Product code: PO185 Product name: POTASSIUM IODIDE,USP
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Hazard statementsCauses eye irritationMay cause an allergic skin reactionSuspected of damaging fertility or the unborn childMay cause respiratory irritationCauses damage to organs through prolonged or repeated exposure
Hazards not otherwise classified (HNOC) Not Applicable
Other hazards Not available
Precautionary Statements - PreventionObtain special instructions before useDo not handle until all safety precautions have been read and understoodWash face, hands and any exposed skin thoroughly after handlingWear protective gloves/protective clothing/eye protection/face protectionContaminated work clothing must not be allowed out of the workplaceUse only outdoors or in a well-ventilated areaDo not breathe dust/fume/gas/mist/vapors/sprayDo not eat, drink or smoke when using this product
Precautionary Statements - Response
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Ifeye irritation persists: Get medical advice/attention.IF ON SKIN: Wash with plenty of waterIf skin irritation or rash occurs: Get medical advice/attentionWash contaminated clothing before reuseIF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER or doctor/physician if youfeel unwell.
Precautionary Statements - StorageStore locked upStore in a well-ventilated place. Keep container tightly closed
Precautionary Statements - DisposalDispose of contents/container to an approved waste disposal plant
3. COMPOSITION/INFORMATION ON INGREDIENTS
Components CAS-No. Weight %Potassium Iodide 7681-11-0 100
4. FIRST AID MEASURES
First aid measures
General Advice: National Capital Poison Center in the United States can provide assistance if youhave a poison emergency and need to talk to a poison specialist. Call1-800-222-1222.
Skin Contact: Wash off immediately with soap and plenty of water removing all contaminated clothing andshoes. Get medical attention if irritation develops. Consult a physician if necessary.
Eye Contact: Flush eyes with water for 15 minutes. Get medical attention if irritation occurs. If symptomspersist, call a physician.
Product code: PO185 Product name: POTASSIUM IODIDE,USP
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Inhalation: Move to fresh air. If not breathing, give artificial respiration. If breathing is difficult, giveoxygen. Get medical attention.
Ingestion: Do not induce vomiting without medical advice. Never give anything by mouth to anunconscious person. Consult a physician if necessary.
Most important symptoms and effects, both acute and delayed
Symptoms Causes eye irritationEye contact may result in redness or painMay cause an allergic skin reactionMay cause irritation of respiratory tractCauses digestive (gastrointestinal) tract irritationIngestion may cause nausea, vomiting, and diarrheaMay affect respirationDyspnea (Shortness of breath and difficulty breathing)It may affect the thyroidCentral nervous system effectsMay cause headacheDrowsinessSomnolenceMay cause iodism
Indication of any immediate medical attention and special treatment needed
Notes to Physician: Treat symptomatically.
Protection of first-aidersFirst-Aid Providers: Avoid exposure to blood or body fluids. Wear gloves and other necessary protective clothing. Dispose ofcontaminated clothing and equipment as bio-hazardous waste.
5. FIRE-FIGHTING MEASURES
Extinguishing Media Suitable Extinguishing Media: The product is not flammable. If it is involved in a fire,
extinguish the fire using an agent suitable for the type ofsurrounding fire.
Unsuitable Extinguishing Media: No information available.
Specific hazards arising from the chemical
Hazardous Combustion Products: No information available.
Specific hazards: No information available.
Special Protective Actions for Firefighters
Specific Methods: No information available.
Special Protective Equipment for Firefighters: As in any fire, wear self-contained breathing apparatuspressure-demand, MSHA/NIOSH (approved or equivalent)and full protective gear
Product code: PO185 Product name: POTASSIUM IODIDE,USP
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7. HANDLING AND STORAGE
Precautions for safe handling
Technical Measures/Precautions:Provide sufficient air exchange and/or exhaust in work rooms. Avoid dust formation. Keep away from incompatiblematerials.
Safe Handling AdviceWear personal protective equipment. Avoid contact with skin, eyes and clothing. Keep away from heat andsources of ignition. Avoid dust formation. Do not ingest. Do not breathe vapors/dust. Handle in accordance withgood industrial hygiene and safety practice.
Conditions for safe storage, including any incompatibilities
Technical Measures/Storage Conditions:Keep container tightly closed in a dry and well-ventilated place. Store at room temperature in the originalcontainer. Store away from incompatible materials. Protect from moisture. Moisture sensitive. Protect from light.Sensitive to light. Store in light-resistant containers.
Incompatible Materials:Alkali MetalsMetalsOrganic materialsReducing agentsStrong acidsOxidizing agentsMercurous chloride
8. EXPOSURE CONTROLS/PERSONAL PROTECTIONControl parameters
National occupational exposure limits
United States
Components CAS-No. OSHA NIOSH ACGIH AIHA WEELPotassium Iodide 7681-11-0 None None None None
6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protective equipment and emergency procedures
Personal Precautions: Ensure adequate ventilation. Keep people away from and upwind of spill/leak. Use personalprotective equipment. Avoid contact with skin, eyes and clothing. Do not touch damagedcontainers or spilled material unless wearing appropriate protective clothing. Avoidbreathing dust.
Environmental precautions Prevent further leakage or spillage if safe to do so. Prevent product from enteringdrains. Prevent entry into waterways, sewers, basements or confined areas.
Methods and material for containment and cleaning up
Methods for containment Stop leak if you can do it without risk. Cover with plastic sheet to preventspreading.
Methods for cleaning up
Product code: PO185 Product name: POTASSIUM IODIDE,USP
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Sweep up and shovel into suitable containers for disposal. Clean contaminatedsurface thoroughly.
Canada
Components CAS-No. Canada - Alberta Canada - BritishColumbia
Canada - Ontario Canada - Quebec
Potassium Iodide 7681-11-0 None None None None
Australia and Mexico
Components CAS-No. Australia MexicoPotassium Iodide 7681-11-0 None None
Appropriate engineering controls
Engineering measures to reduce exposure: Ensure adequate ventilation. Use process enclosures,local exhaust ventilation, or other engineering controls tokeep airborne levels below recommended exposure limits.If user operations generate dust, fume or mist, useventilation to keep exposure to airborne contaminantsbelow the exposure limit.
Individual protection measures, such as personal protective equipment
Personal Protective Equipment
Eye protection: Safety glasses with side-shields or Goggles
Skin and body protection: Long sleeved clothingChemical resistant apronGloves
Respiratory protection: Effective dust mask. Use a dust respirator under conditions where exposure tothe substance is apparent (e.g. generation of high concentration of dust (dustclouds) , inadequate ventilation, development of respiratory tract irritation), andengineering controls are not feasible. Be sure to use an approved/certifiedrespirator or equivalent.
Hygiene measures: Avoid contact with skin, eyes and clothing. Wash hands before breaks andimmediately after handling the product. When using, do not eat, drink or smoke.
9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state:Solid
Appearance:Crystals. Crystalline. Granular.Granular powder.
Color:White.
Odor:Odorless.
TasteBitter. Saline.
Formula:KI
Molecular/Formula weight (g/mole):166.00
Flammability:No information available
Flashpoint (°C/°F):No information available.
Flash Point Tested according to:Not available
Autoignition Temperature (°C/°F):No information available
Lower Explosion Limit (%):No information available
Upper Explosion Limit (%):No information available
Melting point/range(°C/°F):681°C/1257.8°F
Decomposition temperature(°C/°F):No information available
Boiling point/range(°C/°F):
Product code: PO185 Product name: POTASSIUM IODIDE,USP
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10. STABILITY AND REACTIVITYReactivity Reactive with acidsReactive with metalsReactive with oxidizing agentsReacts with reducing agentsReactive with organic materialsMercurous chloride in the presence of an excess of potassium iodide produces metallic mercury and mercuric iodide, the latterforming the soluble double salt, potassium mercuric iodideReacts violently with strong oxidizers (bromotrifluorides, chlorotrifluorides, fluorine perchlorate), metallic salts.Attacks metals inmoist environments.Also incompatible with salts of alkaloids, chloral hydrate, calomel (mercurous chloride), potassium chlorate,tartaric and other acids, oxidants, diazonium salts, charcoal, ozone, strong reducers, alkali metals, metals (brass, aluminummagnesium, zinc, cadmium, copper, tin, nickel, steel)
Chemical stability
Stability: Stable under recommended storage conditions.
Possibility of Hazardous Reactions: Hazardous polymerization does not occur
Conditions to avoid: Heat. Ignition sources. Incompatible materials. Exposure to light. Exposure tomoisture. Becomes yellow on exposure to air. Light and moisture accelerate thedecompositon.
Incompatible Materials: Alkali MetalsMetalsOrganic materialsReducing agentsStrong acidsOxidizing agentsMercurous chloride
Hazardous decomposition products:
Hydrogen iodide. Oxides of potassium. Iodine.
Other Information Corrosivity: No information available
Special Remarks on Corrosivity: No information available
1330°C/2426°F Bulk density:No information available
Density (g/cm3):No information available
Specific gravity:3.1
pH:No information available
Vapor pressure @ 20°C (kPa):No information available
Evaporation rate:No information available
Vapor density:No information available
VOC content (g/L):No information available
Odor threshold (ppm):No information available
Partition coefficient(n-octanol/water):No information available
Viscosity:No information available
Miscibility:No information available
Solubility:Easily soluble in cold waterEasily soluble in waterSoluble in MethanolPartially soluble in acetone
Product code: PO185 Product name: POTASSIUM IODIDE,USP
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11. TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Principal Routes of Exposure:Ingestion. Inhalation.
Acute Toxicity
Component Information
Potassium IodideCAS-No. 7681-11-0
LD50/oral/rat = No information availableLD50/oral/mouse = 1862 mg/kg, LDLoLD50/dermal/rabbit = No information availableLD50/dermal/rat = No information availableLC50/inhalation/rat = No information availableLC50/inhalation/mouse = No information availableOther LD50 or LC50information = 916 mg/kg, oral, rabbit, LDLo
Product Information
LD50/oral/rat =VALUE- Acute Tox Oral = No information available
LD50/oral/mouse =Value - Acute Tox Oral = No information available
LD50/dermal/rabbitVALUE-Acute Tox Dermal = No information available
LD50/dermal/ratVALUE -Acute Tox Dermal = No information available
LC50/inhalation/ratVALUE-Vapor = No information availableVALUE-Gas = No information availableVALUE-Dust/Mist = No information available
LC50/Inhalation/mouseVALUE-Vapor = No information availableVALUE - Gas = No information availableVALUE - Dust/Mist = No information available
Symptoms
Skin Contact: May cause skin irritation. It may cause mild skin irritation. May cause allergiccontact dermatitis.
Eye Contact: Causes eye irritation. Mild eye irritation.
Inhalation May cause respiratory tract and mucous membrane irritation and a productivecough. May cause pulmonary edema and inflammation of the tonsils.
Ingestion Causes gastrointestinal tract irritation with nausea, vomiting and diarrhea. Mayaffect behavior(somnolence, muscle weakness), respiration (dyspnea).
Product code: PO185 Product name: POTASSIUM IODIDE,USP
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Serum-sickness type of hypersensitivity such as fever, arthralgia, lymph nodeenlargement , and eosinophilia may appear. Thrombotic thrombocytopenicpurpura, and fatal periarteritis nodosa attributed to hypersensitivity to iodide hasbeen described.
Aspiration hazard No information available.
Delayed and immediate effects as well as chronic effects from short and long-term exposure
Chronic Toxicity Can lead to iodism characterized by salivation, metallic taste, sore mouth, nausea,vomiting, epigastric pain, diarrhea, nasal discharge, sneezing, conjunctivitis, fever,headache, laryngitis, bronchitis, stomatits, parotitis, anemia, and skin rashes.Chronic ingestion may also affect metabolism (anorexia), and thyroid gland(hypothyroidism, goiter). Furthermore, chronic ingestion of iodides (in animals)during pregnancy has resulted in fetal deaths, severe goiter and cretinoidappearance of the newborn. Prolonged or repeated skin contact may causeallergic reaction.
Sensitization: May cause sensitization by skin contact.
Mutagenic Effects: May affect genetic material based on animal test dataNo human data found
Carcinogenic effects: Not considered carcinogenic.
Components CAS-No. IARC ACGIH -Carcinogens
NTP OSHA HCS -Carcinogens
Australia -Notifiable
CarcinogenicSubstances
Australia -Prohibited
CarcinogenicSubstances
Potassium Iodide 7681-11-0 Not listed A4 - NotClassifiable asa HumanCarcinogen(listed asIodides)
Not listed Not listed Not listed Not listed
ACGIH (American Conference of Governmental Industrial Hygienists)
IARC (International Agency for Research on Cancer)
NTP (National Toxicology Program)
OSHA (Occupational Safety and Health Administration of the US Department of Labor)
Reproductive toxicity Suspected of damaging fertility or the unborn child
Reproductive Effects: No information availableDevelopmental Effects: No information availableTeratogenic Effects: No information available
Specific Target Organ Toxicity
STOT - single exposure Respiratory system.STOT - repeated exposure Causes damage to organs through prolonged or repeated exposure.Target Organs: Thyroid.
12. ECOLOGICAL INFORMATION
Ecotoxicity
Product code: PO185 Product name: POTASSIUM IODIDE,USP
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Ecotoxicity effects: No data available.
Persistence and degradability: No information available
Bioaccumulative potential: No information available.
Mobility: No information available.
13. DISPOSAL CONSIDERATIONS
Disposal Methods
Waste from residues / unused products:Waste must be disposed of in accordance with Federal, State and Local regulation.
Contaminated packaging:Empty containers should be taken for local recycling, recovery or waste disposal
Components CAS-No. RCRA - F SeriesWastes
RCRA - K SeriesWastes
RCRA - P SeriesWastes
RCRA - U SeriesWastes
Potassium Iodide 7681-11-0 None None None None
14. TRANSPORT INFORMATION
DOTUN-No: Not RegulatedProper Shipping Name: No information availableHazard Class: No information availableSubsidiary Class No information availablePacking group: No information availableEmergency Response GuideNumber
No information available
Marine Pollutant No data availableDOT RQ (lbs): No information availableSpecial Provisions No Information availableSymbol(s): No information availableDescription: No information available
TDG (Canada)UN-No: Not RegulatedProper Shipping Name: No information availableHazard Class: No information availableSubsidiary Risk: No information availablePacking Group: No information availableMarine Pollutant No Information availableDescription: No information available
ADRUN-No: Not RegulatedProper Shipping Name: No information availableHazard Class: No information availablePacking Group: No information availableSubsidiary Risk: No information available
IMO / IMDGUN-No: Not Regulated
Product code: PO185 Product name: POTASSIUM IODIDE,USP
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Proper Shipping Name: No information availableHazard Class: No information availableSubsidiary Risk: No information availablePacking Group: No information availableMarine Pollutant No information available
RIDUN-No: Not RegulatedProper Shipping Name: No information availableHazard Class: No information availableSubsidiary Risk: No information availablePacking Group: No information available
ICAOUN-No: Not RegulatedProper Shipping Name: No information availableHazard Class: No information availableSubsidiary Risk: No information availablePacking Group: No information available
IATAUN-No: Not RegulatedProper Shipping Name: No information availableHazard Class: No information availableSubsidiary Risk: No information availablePacking Group: No information availableERG Code: No information availableSpecial Provisions No information available
15. REGULATORY INFORMATION
International Inventories
Components CAS-No. U.S. TSCA KOREA KECL Philippines(PICCS)
Japan ENCS CHINA Australia(AICS)
EINECS-No.
Potassium Iodide 7681-11-0 PresentACTIVE
PresentKE-29149
Present Present(1)-439
Present Present Present231-659-4
U.S. Regulations
Potassium IodideFDA - Food Additives Generally Recognized as Safe (GRAS): 21 CFR 184.1634
FDA - Direct Food Additives 21 CFR 172.375FDA - 21 CFR - Total Food Additives 100.155, 172.375, 178.1010, 184.1634, 582.80
California Prop. 65: Safe Drinking Water and Toxic Enforcement Act of 1986.
Chemicals Known to the State of California to Cause Cancer:This product does not contain a chemical requiring a warning under California Prop. 65. (See table below)
Chemicals Known to the State of California to Cause Reproductive Toxicity:This product does not contain a chemical requiring a warning under California Prop. 65. (See table below)
Components CAS-No. Carcinogen Developmental Toxicity MaleReproductiveToxicity
FemaleReproductiveToxicity:
Potassium Iodide 7681-11-0 Not Listed Not Listed Not Listed Not Listed
CERCLA/SARA
Components CAS-No. CERCLA - Section 302 Section 302 Section 313 - Section 313 -
Product code: PO185 Product name: POTASSIUM IODIDE,USP
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HazardousSubstances andtheir Reportable
Quantities
ExtremelyHazardousSubstancesand TPQs
ExtremelyHazardous
Substances andRQs
Chemical Category Reporting de minimis
Potassium Iodide 7681-11-0 None None None None None
U.S. TSCA
Components CAS-No. TSCA Section 5(a)2 - ChemicalsWith Significant New Use Rules(SNURS)
TSCA 8(d) -Health and SafetyReporting
Potassium Iodide 7681-11-0 Not Applicable Not Applicable
Canada
WHIMIS 2015 - GHS Classifications
WHMIS 2015 Hazard ClassificationInformation:
.
Component WHMIS 2015 Hazard ClassificationPotassium Iodide 7681-11-0 ( 100 )
Specific target organ toxicity - Repeated exposure - Category 1:H372 Causes damage to organs through prolonged or repeatedexposure.
Canada Hazardous Products Regulation This product has been classified according to the hazard criteria of the HPR (HazardousProducts Regulation) and the SDS contains all of the information required by the HPR
WHMIS 1988 Hazard ClassD2A Very toxic materials
Components WHMIS 1988Potassium Iodide D2A
Canada Controlled Products Regulation:This product has been classified according to the hazard criteria of the CPR (Controlled Products Regulation) and the MSDScontains all of the information required by the CPR.
Components WHMIS Ingredient Disclosure List -Potassium Iodide 1 %
Inventory
Components CAS-No. Canada (DSL) Canada (NDSL)Potassium Iodide 7681-11-0 Present Not Listed
Components CAS-No. CEPA Schedule I - Toxic SubstancesPotassium Iodide 7681-11-0 Not listedComponents CAS-No. CEPA - 2010 Greenhouse Gases Subject
to Mandatory ReportingPotassium Iodide 7681-11-0 Not listed
EU Classification
EU GHS - SV - CLP 1272/2008
Components CAS-No. EU GHS - SV - CLP (1272/2008)Potassium Iodide 7681-11-0 No information
EU - CLP (1272/2008)
Product code: PO185 Product name: POTASSIUM IODIDE,USP
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R-phrase(s)Not determined
none
S -phrase(s)none
Components CAS-No. Classification ConcentrationLimits:
Safety Phrases
Potassium Iodide 7681-11-0 No informationThe product is classified in accordance with Annex VI to Directive 67/548/EEC
Indication of danger:not determined
16. OTHER INFORMATION
Preparation Date: 01/22/2015Revision Date: 08/06/2018Prepared by: Sonia Owen
Disclaimer: All chemicals may pose unknown hazards and should be used with caution. ThisSafety Data Sheet (SDS) applies only to the material as packaged. If this productis combined with other materials, deteriorates, or becomes contaminated, it maypose hazards not mentioned in this SDS. The physical properties reported in thisSDS are obtained from the literature and do not constitute product specifications.Information contained herein does not constitute a warranty, whether expressed orimplied, as to the safety, merchantability or fitness of the goods for a particularpurpose. Spectrum Chemicals & Laboratory Products, Inc. assumes noresponsibility for results obtained or for incidental or consequential damages,including lost profits, arising from the use of these data. No warranty againstinfringement of any patent, copyright or trademark is made or implied. It shall bethe user's responsibility to develop proper methods of handling and personalprotection based on the actual conditions of use. While this SDS is based ontechnical data judged to be reliable, Spectrum assumes no responsibility for thecompleteness or accuracy of the information contained herein.
End of Safety Data Sheet
Product code: PO185 Product name: POTASSIUM IODIDE,USP
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C O R P O R A T E H E A D Q U A R T E R S
769 Jersey Avenue
New Brunswick, NJ 08901
PHONE 732.214.1300
FAX 732.246.7132
A N I S O 90 0 1 :2 0 15 RE G IS T E RE D COM P A NY
W E S T C O A S T F A C I L I T Y
14422 South San Pedro Street
Gardena, California 90248
PHONE 310.516.8000
FAX 310.516.9843
w w w . s p e c t r u m c h e m i c a l . c o m
January 08, 2019 Certification of Compliance with current Good Manufacturing Practices Dear Valued Customer: Spectrum Chemical Mfg Corp certifies that our USP, NF, FCC, EP, BP, JP, and food grade products are produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 and parts 110 and 111 of the Code of Federal Regulations, respectively. Spectrum is an FDA registered and inspected Drug Establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows: Spectrum Gardena, California: 2020632 Spectrum New Brunswick, New Jersey: 2246824 Thank you for your interest in Spectrum products. Please feel free to contact me at 310-516-8000, extension 5610 or via email at [email protected] if I may be of further assistance. Sincerely,
Michael Dang Director, Quality Systems & GMP Compliance
mailto:[email protected]
July 26, 2019
Certification of Compliance with current Good Manufacturing Practices
Dear Valued Customer:
Spectrum Chemical Mfg Corp certifies that the following product(s) is produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 of the Code of Federal Regulations.
Catalog Number Product Name PO185 Potassium Iodide, USP
Spectrum is an FDA registered and inspected Drug Establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows:
Spectrum-Gardena, CA: 2020632 Spectrum-New Brunswick, NJ: 2246824 Spectrum-Shanghai, China: 03006174778
Thank you for your interest in Spectrum products. If we may be of further assistance, please feel free to contact the Quality Assurance department at 310-516-8000 or via email at [email protected]
Sincerely,
Oralia Chavez Quality Assurance Specialist
mailto:[email protected]
April 13, 2016 Re: Potassium Iodide, USP- PO185 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfr. Corp. understand the concern regarding Bovine Spongiform Encephalopathy (BSE). Please be assured that the chemical Potassium Iodide, USP- PO185 is BSE/TSE free. If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag- Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature
April 13, 2016 Re: Potassium Iodide, USP-PO185 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfr. Corp. understand the concern regarding the presence of allergens in raw materials. Please be assured that the following chemical does not contain (Dairy products; Egg products, Corn products; Wheat products, Rye products; Barley products; Rice products; Oat products; Soy products., Sunflower products; Safflower products; Celery; Mustards; Sesame seeds; Lupine; Nut products; Peanut products; Chocolate/Chocolate derivatives; Monosodium Glutamate; Sulfur Dioxide; Hydrolyzed proteins; Autolyzed Yeast or Yeast extracts; Sulfites; BHA, BHT, Tocopherols or TBHQ; Beef products or their derivatives; Pork products or their derivatives; Fish/Shellfish products or any other plant or animal byproducts, and Cereals containing Gluten) Potassium Iodide, USP-PO185
If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag- Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature
April 14, 2016 Re: Potassium Iodide, USP- PO185 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfg. Corp. understand the concern regarding Aflatoxins in raw materials. To the best of our knowledge, the product listed below is not contaminated with Aflatoxins. Aflatoxins are not used in production. The following product does not come in contact with Aflatoxins at any stage of production. Potassium Iodide, USP- PO185 If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature
Certificate Of Analysis
Item Number PO185 Lot Number 1IA0559
Item Potassium Iodide, USP Manufacturer Lot 827001
CAS Number 7681-11-0 Manufacturer Code 46
Molecular Formula KI Molecular Weight 166.00
Test Specification Resultmin max
99.0 101.5 % 99.7 %
NO COLOR ISPRODUCED
NO COLOR ISPRODUCED
1.0 % 0.1 %
4 μg/g
The Elemental Impurities standards implemented by USP and other Pharmaceutical Compendia reflect a growing understandingof the toxicology of trace levels of elemental impurities that can remain in drug substances originating from either raw materials ormanufacturing processes. Identifying and quantifying impurities can be critical to predicting the best possible patient outcomes.Elemental Impurities has been a requirement of all products meeting USP/NF, EP and BP monographs since January 1, 2018.More information can be found in USP sections Elemental Impurities – Limits and Elemental Impurities –Procedures. Data for drug substances furnished by Spectrum Chemical Mfg. Corp can be used to ensure that patient dailyexposures by oral administration to the selected elements are not exceeded in the formulation of pharmaceutical products.
Spectrum Chemical Mfg. Corp. repackages Active Pharmaceutical Ingredient chemicals provided by other manufacturers andsuppliers. For traceability purposes, Spectrum's Certificate of Analysis contains an identifier code unique to each manufacturer orsupplier, as well as the chemical's lot number provided on the original manufacturer Certificate of Analysis. Test results for theoriginal Certificate of Analysis are available upon request from your Spectrum Sales Representative or by calling Spectrum'sQuality Department at 1-800-772-8786.
Certificate Of Analysis
Item Number PO185 Lot Number 2IA0108
Item Potassium Iodide, USP Manufacturer Lot 825302
CAS Number 7681-11-0 Manufacturer Code 46
Molecular Formula KI Molecular Weight 166.00
Test Specification Resultmin max
99.0 101.5 % 99.9 %
NO COLOR ISPRODUCED
NO COLOR ISPRODUCED
1.0 % 0.1 %
4 μg/g
The Elemental Impurities standards implemented by USP and other Pharmaceutical Compendia reflect a growing understandingof the toxicology of trace levels of elemental impurities that can remain in drug substances originating from either raw materials ormanufacturing processes. Identifying and quantifying impurities can be critical to predicting the best possible patient outcomes.Elemental Impurities has been a requirement of all products meeting USP/NF, EP and BP monographs since January 1, 2018.More information can be found in USP sections Elemental Impurities – Limits and Elemental Impurities –Procedures. Data for drug substances furnished by Spectrum Chemical Mfg. Corp can be used to ensure that patient dailyexposures by oral administration to the selected elements are not exceeded in the formulation of pharmaceutical products.
Spectrum Chemical Mfg. Corp. repackages Active Pharmaceutical Ingredient chemicals provided by other manufacturers andsuppliers. For traceability purposes, Spectrum's Certificate of Analysis contains an identifier code unique to each manufacturer orsupplier, as well as the chemical's lot number provided on the original manufacturer Certificate of Analysis. Test results for theoriginal Certificate of Analysis are available upon request from your Spectrum Sales Representative or by calling Spectrum'sQuality Department at 1-800-772-8786.
SPECTRUM CHEMICAL MFG. CORP. Gardena, CA 90248 • New Brunswick, NJ 08901
Chemical Emergency: (800)424-9300*49452PO185062233BOA* PO185 2.5 KG
Potassium IodideU.S.P.
CAS 7681-11-0
CAUTION: For manufacturing, processing or repacking.Read and understand the label and Safety Data Sheet (SDS) prior to use.
WARNING• Causes eye irritation • May cause respiratory irritation • May cause an allergic skin reaction • Suspected of damaging fertility or the unborn child. • Obtain special instructions before use • Do not handle until all safety precautions have been read and understood • Wear protective gloves, protective clothing, eye protection, face protection • Avoid breathing dust • Use only outdoors or in a well-ventilated area • Wash face, hands and any exposed skin thoroughly after handling • Contaminated clothing should not be allowed out of the workplace.FIRST AID: Call a POISON CENTER of physician if you feel unwell. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical attention. IF ON SKIN: Wash with plenty of water. Wash contaminated clothing before reuse. If skin irritation or rash occurs: Get medical attention. IF INHALED: Remove person to fresh air and keep comfortable for breathing.
KEEP FROM CHILDRENG 14/E1GHS A Lot No. 062233
KI F.W. 166.00Assay .............................................. 99.0-101.5%Alkalinity ...........................................To pass test
MAXIMUM LIMITSLoss on Drying ............................................ 1.0%Iodate .................................................... 0.0004%Nitrate, Nitrite and Ammonia .............To pass testThiosulfate, Barium ...........................To pass testHeavy Metals ........................................... 0.001%Residual Solvents .............................To pass testWARNING: This product contains a chemical known to the State of California to cause cancer.WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.LIGHT SENSITIVE, MOISTURE SENSITIVE: Keep tightly closed in light-resistant containers.
www.SpectrumChemical.com
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Empirical Formula, Formula Weight and Technical Specifications Panel
Expiration Information
Lot Number
Kosher Certified by Kosher Supervision of America (KSA).
Bar CodeGHS Hazard PictogramsWarning, Safety Data and Precautionary InformationProduct Catalog NumberItem Name, Form, Grade
Size/Quantity
Chemical Abstracts Service (CAS) Registry Number
Caution Information
Toll-Free 24-Hour Chemical Emergency Telephone Number
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YELLOW: Oxidizer
RED: Flammable
GREEN: General Storage
BLUE: Health Hazard
WHITE: Corrosive
Storage Color Band
This color-coded band indicates the hazard most likely to be posed by that material under storage conditions. The criteria used to assign band colors have been established by the Storage Code working group of the Society for Chemical Hazard Communication (SCHC). It is recommended that like colors be stored together, unless otherwise stated, based on the color codes indicated to the right. However, it is the responsibility of the customer to check with their local fire department for possible conflicts with our recommendations when storing hazardous chemicals.
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The Spectrum label presents technical and safety information in an easily understood format. Our technical specialists stay abreast of the latest requirements of the Globally Harmonized System for Classification and Labelling of Chemicals (GHS), as well as the Occupational Safety and Health Administration (OSHA), the Food and Drug Administration (FDA) and other government regulatory agencies in order to ensure compliance, accuracy and concise hazard communication.
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Spectrum Chemical Mfg Corp
Corporate Headquarters: West Coast Facility:
769 Jersey Ave. 14422 S. San Pedro St.
New Brunswick, NJ 08901 Gardena, CA 90248
732.214.1300 310.516.8000
Label Information
N
N
C O R P O R A T E H E A D Q U A R T E R S
769 Jersey Avenue
New Brunswick, NJ 08901
PHONE 732.214.1300
FAX 732.246.7132
A N I S O 90 0 1 :2 0 15 RE G IS T E RE D COM P A NY
W E S T C O A S T F A C I L I T Y
14422 South San Pedro Street
Gardena, California 90248
PHONE 310.516.8000
FAX 310.516.9843
w w w . s p e c t r u m c h e m i c a l . c o m
February 1, 2019 RE: Lot Numbering System Dear Valued Customer: This letter is to inform you of Spectrum Chemicals and Laboratory Products’ Lot Numbering System. The system is based on an alpha-numerical sequence which provides the month, year and location of production. The lot numbering system utilized until 2010 is a sequence of six characters, two letters followed by four numbers. The first letter represents the year, for example, Y denotes 2009 and Z denotes 2010. The second letter represents the month and site, for example, A-L denotes January through December at Spectrum’s Gardena, CA facility, while M-X denotes January through December at the New Brunswick, NJ facility. The following four numbers are sequentially assigned. Example: ZI0928 = The 928th material produced in California in September 2010 The lot numbering system utilized for 2011 and forward, is a sequence of seven characters. The first character, a number, represents the production facility: 1 = Gardena, CA Facility 2 = New Brunswick, NJ Facility 3 = China Facility 4 = Pharmacy, NJ Facility The second character, a letter, represents the year. For example, A denotes 2011 and B denotes 2012. The third character, a letter, represents the month, with A denoting January and L denoting December. The following four numbers are sequentially assigned. Example: 2AA0706 = The 706th material produced in New Jersey in January 2011 Thank you for your interest with Spectrum products. Please feel free to contact us at 310-516-8000 or via email at [email protected] if we may be of further assistance.
Sincerely,
Howard Lau, Quality Assurance Specialist
26.July.2019
Stability – Shelf Life Guidance Product Covered: PO185, Potassium Iodide, USP Spectrum Chemical’s manufacturing partner has assigned the following shelf life guidance for the product listed above. The product, PO185, Potassium Iodide, USP, is assigned a 36 months shelf life from date of manufacturing. The quality and integrity of the chemical depends on the handling and storage conditions. Please refer to the Safety Data Sheet for proper storage and handling procedures. Adan R. Hernandez Quality Control Manager
Corporate Headquarters 769 Jersey Avenue New Brunswick, NJ 08901-3605
Document id:
The following product(s) prepared by the named company are certied kosher with the stated requirements:
This certicate expires on
Placing the KSA logo on products not listed above constitutes an un-authorized use of the KSA symbol, which is a federally registered trademark.
Rabbi Binyomin LisbonKashrus Administrator
P.O.Box 35721, Los Angeles, Ca 90035 - (310) 282-0444 - Fax (310) 282-0505 - Email [email protected] - www.ksakosher.com
בס’’ד
Product Name
Brand
UKD-ID
D/P/M
Symbol Required
Special Conditions
S-0032
Spectrum Laboratory Products, Inc.
Feb 04, 2019
PO185, Potassium Iodide, USP
Spectrum
KSAV3-Q7L2N58
P
KSA
Feb 01, 2020
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14422 S. San Pedro StreetGardena, CA 90248
USA
ProductName Product Code Halal-ID Product Certificate #
1. Potassium Iodide, USP PO185 B94034 HC-19SP1X66
This is to certify that the following product(s) have been produced under the supervision of the Islamic Food and Nutrition Council of America(IFANCA).The production facility as well as component ingredients have been reviewed and approved. The product(s) are in compliance with the halal requirements underIslamic laws.
Date: June 18, 2019
Document #: 11205.11209.II191058
Company Name & Address: Spectrum Laboratory Products, Inc. 755-769 Jersey Ave New Brunswick, New Jersey 08901 USA
Plant Name & Address: Spectrum Laboratory Products, Inc. 14422 South San Pedro Street Gardena, California 90248 USA
Muhammad Munir Chaudry, Ph.D.President
This Certificate is valid until August 31, 2020 and subject to renewal at that time.
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