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Product Code: P22101 Version: 5 Page 1 of 15 PRODUCT TECHNICAL DOSSIER VITAMIN B3 (NICOTINIC ACID) Product Code: P22101 Raw Material Full Name: Pyridine-3-Carboxylic Acid This material is Food Grade This material Vegan/Vegetarian Suitable Limit/Range/Specification: 99.5%-100.5% CAS Number: 59-67-6 EC/EINECS Number: 200-441-0 Molecular Formula for the raw material: C6H5NO2 Average Molecular weight: 123.11 Solubility in Water: Slightly Soluble: 100ml Water under 20◦C is 0.01g-1g Solubility in Alcohol: Slightly Soluble Particle Size: 120 Mesh Percentage passed through: > 90%

PRODUCT TECHNICAL DOSSIER VITAMIN B3 (NICOTINIC … · PRODUCT TECHNICAL DOSSIER VITAMIN B3 (NICOTINIC ACID) Product Code: P22101 Raw Material Full Name: Pyridine-3-Carboxylic Acid

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Page 1: PRODUCT TECHNICAL DOSSIER VITAMIN B3 (NICOTINIC … · PRODUCT TECHNICAL DOSSIER VITAMIN B3 (NICOTINIC ACID) Product Code: P22101 Raw Material Full Name: Pyridine-3-Carboxylic Acid

Product Code: P22101 Version: 5 Page 1 of 15

PRODUCT TECHNICAL DOSSIER

VITAMIN B3 (NICOTINIC ACID) Product Code: P22101 Raw Material Full Name: Pyridine-3-Carboxylic Acid This material is Food Grade

✓ This material Vegan/Vegetarian Suitable

✓ Limit/Range/Specification: 99.5%-100.5% CAS Number: 59-67-6 EC/EINECS Number: 200-441-0 Molecular Formula for the raw material: C6H5NO2 Average Molecular weight: 123.11 Solubility in Water: Slightly Soluble: 100ml Water under 20◦C is 0.01g-1g Solubility in Alcohol: Slightly Soluble Particle Size: 120 Mesh Percentage passed through: > 90%

Page 2: PRODUCT TECHNICAL DOSSIER VITAMIN B3 (NICOTINIC … · PRODUCT TECHNICAL DOSSIER VITAMIN B3 (NICOTINIC ACID) Product Code: P22101 Raw Material Full Name: Pyridine-3-Carboxylic Acid

Product Code: P22101 Version: 5 Page 2 of 15

Bulk Density: 0.5-0.6g/ml Tapped Density: 0.7-0.8g/ml pH: 3.5 Loss on Drying: Max 1% Residue on Ignition: Max 0.1% Country of Origin: China Country of Origin of the Manufacture: China Base Source/Start Material: 3-Cyanopyridine Origin of Product – Synthetic, Plant, Mineral, Animal, Fish or Fermented: Synthetic Material is: 100% Compound Ingredients Origin, Function and Percentages: None Shelf Life from Date of Manufacture: Min 3 Years Storage Conditions: Store in a well-sealed container, put in a cool, dry, light proof place.

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Product Code: P22101 Version: 5 Page 3 of 15

Appearance (Fine/Crystals/Crystalline/Hygroscopic): Crystalline Powder Colour: White/Off White Flavour/Taste: Characteristic Odour: Characteristic

Microbiological Test (Tested Periodically) Total Viable Count: Max 1,000 cfu/g Yeast & Moulds: Max 200 cfu/g E.Coli: Negative Salmonella: Negative Heavy Metals Heavy Metals: Max 20ppm Lead (Pb): Max 3ppm Cadmium (Cd): Max 1ppm Mercury (Hg): Max 0.1ppm Arsenic (As): Max 1ppm

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Product Code: P22101 Version: 5 Page 4 of 15

There are no nuts in this recipe, however we cannot guarantee that the raw materials entering the site are nut free. Please note that surveillance testing may mean that not all the parameters stated on this specification are tested for every batch.

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Product Code: P22101 Version: 5 Page 5 of 15

ALLERGENS Product Contains YES/NO

Listed Item on Site at

Manufacturer YES/NO

If YES, Please Comment

Peanuts and Peanut Derivatives (including possible cross contamination) NO NO other Nut and Nut Derivatives Almond (Amygdalus communis L.), Hazelnut (Corylus avellana), Walnut (Juglans regia), Cashew (Anacardium occidentale), Pecan nut (Carya illinoiesis (Wangenh.) K. Koch), Brazil nut (Bertholletia excelsa), Pistachio nut (Pistacia vera), Macadamia nut and Queensland nut (Macadamia ternifolia)

NO NO

Sesame Seeds and Sesame Seed Derivatives NO NO

other Seeds and Seed Derivatives (Poppy Seeds, Cotton Seeds, Sunflower Seeds) NO NO

Milk and Milk Derivatives (including lactose) NO NO

Egg and Egg Derivatives NO NO

Cereals and Derivatives containing OR POTENTIALLY CONTAMINATED WITH Gluten (wheat, wheatgrass, faro, freekeh, spelt, kamut, rye, oats, barley, barley grass)

NO NO

Soya and Soya Derivatives NO NO

Lupin and Lupin Derivatives NO NO

Mustard and Mustard Derivatives NO NO

Celery or Celery Derivatives (including Celeriac) NO NO

Fish and Fish Derivatives NO NO

Molluscs and their Derivatives NO NO

Crustaceans and their Derivatives NO NO

Sulphur Dioxide and Sulphites (E220, E228) at levels > 10mg/kg or 10mg/litre NO NO

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Product Code: P22101 Version: 5 Page 6 of 15

ADDITIVES / CONTAMINANTS / DIETARY REQUIREMENTS Product Contains YES/NO

Listed Item on Site at

Manufacturer YES/NO

If YES, Please Comment

Additives NO NO

Antioxidants NO NO

Ethylene Oxide NO NO

Gelatine NO NO

Flavourings (Artificial / Nature Identical / Natural / Smoked) NO NO

Maize / Corn and any Derivatives NO NO

Legumes / Pulses NO NO

Rice and Rice Derivatives NO NO

Added Salt NO NO

Added Sugar / artificial or natural sweeteners NO NO

Aspartame NO NO

BHA / BHT (E320 / E321) NO NO

Caffeine NO NO

Colours (Artificial / Nature Identical / Natural / Smoked) NO NO

Dextrose NO NO

Dioxins NO NO

MSG (Added and Naturally Occurring E621) or Glutamates (E620 to E625) NO NO

Nucleotides (E627, E630, E631, E635) NO NO

Polyols (sugar alcohols) NO NO

Benzoates (E210 / E219) NO NO

Sorbic Acid (E200, E203) NO NO

any other Preservatives NO NO

Ethanol NO NO

Honey NO NO

Lactose NO NO

Yeast and Yeast Derivatives NO NO

All Animal Products (Beef, Pork, Poultry or other) and Derivatives (which may include growth/yield hormones, antibiotics etc.)

NO NO

Bovine Products or Derivatives (which may include growth/yield hormones, antibiotics etc.)

NO NO

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Product Code: P22101 Version: 5 Page 7 of 15

PRODUCTION FLOW CHART

3-Cyanopyridine + Liquid Caustic Soda

Hydrolysis

Neutralising and Decolouration

Filter Pressing

Acidification

Rejection Filter

Drying

Sifting

Packaging

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Product Code: P22101 Version: 5 Page 8 of 15

CONFIRMATION OF BSE/TSE STATUS This is to certify that this product complies with all relevant current UK and EU Legislative requirements in regard to Transmissible Spongiform Encephalopathies (TSE) and Bovine Spongiform Encephalopathy (BSE) for human food, and so is free of TSE/BSE. This is also to certify that, during the course of their manufacture, the above-mentioned product did not come into contact with any materials, which could be derived from TSE/BSE risk materials. CONFIRMATION OF GM STATUS This is to certify that this product is not manufactured from GM raw materials and is therefore not subject to labelling under regulations 1829/2003/EC and 1830/2003/EC. CONFIRMATION OF NON IRRADIATION STATUS This is to certify that this product, whole or in part, has not been subjected to Ionising Radiation as per European Directives 1999/3/EC. CONFIRMATION OF NANDROLONE STATUS This is to certify that this product, whole or in part, has not come into contact with Nandrolone or any of its precursors in any way. CONFIRMATION OF IOC PRODUCT STATUS This is to certify that this product, whole or in part, has not come into contact with any product/s, which is banned by the IOC (International Olympics Committee) and or WADA.

CONFIRMATION OF ANIMAL TESTING STATUS This is to certify that all the products sold by Cambridge Commodities have not been tested on animals in any part of its manufacture in accordance with regulation 86/609/EEC. CONFIRMATION OF PESTICIDES STATUS This is to certify that the above-mentioned product complies with the regulation (EC) No.396/2005 of 23rd February 2005 and commission Regulation (EU) No. 559/2011 of 7th June 2011 amending annexes II and III of the above Regulation. CONFIRMATION OF NANOPARTICLE STATUS This is to certify that unless otherwise stated, the above-mentioned product is free of nanoparticles. Commission Recommendation 2011/696/EU, defines as follows: "'Nanomaterial' means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm".

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Product Code: P22101 Version: 5 Page 9 of 15

MATERIAL SAFETY DATA SHEET

1. Identification of the substance/preparation

Product name: Vitamin B3 (NICOTINIC ACID) Product Code: P22101 Company: Cambridge Commodities Limited

Lancaster Way, Ely, Cambridgeshire, CB6 3NX. Tel: 01353 667258. Email: [email protected]

2. Hazards Identification

May cause irritation to eyes.

2. Ingredients/Identity information

Composition Nicotinic Acid (Formula C6H5NO2) CAS Number: 59 – 67 – 6 EINECS Number: 200-441-0 % in Product: Min 99%

4. Emergency and First Aid Procedures

Eyes In the case of contact with eyes, rinse immediately with plenty of water and seek medical

advice. Call a physician immediately Skin After contact with skin, wash immediately with plenty of soap and water. Consult a physician Swallowing Call a physician immediately. Clean mouth with water and drink afterwards plenty of water.

Do not induce vomiting without medical advice. Never give anything by mouth to an unconscious person.

Inhalation Remove to fresh air. If breathing is difficult, administer artificial respiration Note to Physician: Symptoms: After skin contact, inhalation or swallowing: Heat sensation and reddening of the skin or face

(Flushing syndrome)

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Product Code: P22101 Version: 5 Page 10 of 15

5. Fire and Hazard Data

Suitable extinguishing media Water spray, dry powder, foam Specific hazards during fire-fighting Heating or fire can release toxic gas. Special protective equipment for fire-fighters In the event of fire, wear self-contained breathing apparatus. Additional advice Use water spray to cool unopened containers.

Section 6 Accidental release measures.

Personal precautions Avoid dust formation. Use personal protective equipment. Environmental precautions Prevent product from entering drains. Methods for cleaning up Sweep up or vacuum up spillage and collect in suitable container for disposal.

Do not flush into surface water or sanitary sewer system.

7. Storage and Handling

Handling Safe handling advice: Provide sufficient air exchange and/or exhaust in work

rooms. Avoid formation of respirable particles. Avoid contact with skin and eyes.

Advice on protection against fire and explosion: Avoid dust formation Storage Requirements for storage areas and containers: To maintain product quality,

do not store in heat or direct sunlight. Keep container tightly closed. Keep in a dry, cool and well-ventilated place.

8. Control Methods/Personal Protection

Respiratory Protection Where dust or particulates are generated by the process, wear dust filter

mask Hand/Body Protection Rubber or plastic gloves Skin and Body Protection Wear suitable protective clothing and gloves Eye Protection Wear eye/face protection Wear as appropriate Dust impervious protective suit

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Product Code: P22101 Version: 5 Page 11 of 15

9. Physical and Chemical Properties

Change in physical State Solid

Form Powder

Colour White

Odour Odourless

Safety Data

pH Approx. 3.4 (10 g/l ; 20 °C)

Melting Point/Range 234.0 – 237.0 °C

Flash Point 193 °C

Ignition Temperature > 365 °C , deposited dust, (BZl) no ignition

> 440 °C , dispersed dust cloud, react. with flame

Lower Explosion Limit 25 g/m3

Vapour Pressure 0.1 mbar (50 °C)

Method Calculated

Density 1,466 g/cm3 (20 °C)

Bulk Density 650 - 750 g/1

Water Solubility 15 g/l (20 °C)

150 g/l (]00 °C)

Solubility Ethanol: 12.5 g/l (25 °C) LogPow (n-octanol/Water) -0.59 (25 °C)

Other Data

Burning Number BZ 5: Slow, quiet burning with flames (20 °C)

BZ 5: Slow, quiet burning with flames (100 °C)

Method: Source of Ignition: glowing platinum wire, 1000oC Approx.

Impact Sensitivity: No impact

Method: Drop hammer test

Dust explosion class: St(H)2: strong dust explosion, indicator 2; K 2: strong explosion potential

Kst-value (Kmax-value): 236 m.b_/s (m.b_/s=bar*m*s-1)

Maximum explosion pressure: 8.3 bar

Minumum ignition energy: 1-5 mJ

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Product Code: P22101 Version: 5 Page 12 of 15

10. Stability and Reactivity

Conditions to avoid: No data available Hazardous reactions Stable under normal conditions.

11. Toxicological Information

Acute oral toxicity (LD50) : > 5000 mg/kgSpecies: RatMethod: DOT

Acute dermal toxicity (LD50) : > 2000 mg/kgSpecies: RatMethod: OECD Test Guideline 402

Skin irritation : Non-irritant Species: Rabbit Exposure time: 4h Method: DOT

Eye irritation : Moderate irritant Species: Rabbit Method: OECD Test Guideline 405

Sensitization : Not sensitizing Species: guinea pig Magnusson & Kligman Method: OECD Test Guideline 406

Genotoxicity in vivo Negative Ames test, Salmonella typhimurium

Method: OECD 471 Negative

Chromosome aberration test in vitro, CHO cells Method: OECD 473

Negative Genotoxicity, CHO cells Method: OECD 476

Negative

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Product Code: P22101 Version: 5 Page 13 of 15

UDS in vitro, rat hepatocytes Method: OECD 482 negative Chromosome aberration test in vivo

Genotoxicity in vivo: Negative Species: Rat Method: OECD 475

12. Ecological Information

Ecotoxicity effects Toxicity to fish (LC50) : 520 mg/l Species: Rainbow trout Acute toxicity Exposure time: 96 h Method: OECD Test Guideline 203

Toxicity to daphnia (EC50) : 77 mg/l Species: Daphnia magna Immobilization Immobilisation Exposure time: 48 h Method: DIN 38412 L 11

Toxicity to algae (EbC50) : 90 mg/l Species: Scenedesnms sp. Growth inhibition Exposure time: 72 h Method: OECD Test Guideline 201

Toxicity to bacteria (EC50) : 120 mg/I Species: Pseudomonas sp. Growth inhibition Method: DIN 38412 Part 8

Persistence and degradability Biodegradability : Modified OECD Screening Test: 100,0 % Readily biodegradable. Testing period: 14 d Method: OECD 30 IE

Bioaccumulative potential Bioaccumulation : Does not bioaccumulate.

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Product Code: P22101 Version: 5 Page 14 of 15

13. Disposal Considerations

Waste from residues The organic ingredients can be incinerated in a suitable installation when in accordance with local regulations.

Contaminated packaging Where possible recycling is preferred to disposal or incineration.

14. Transport Information

ADR: Not dangerous goods RID: Not dangerous goods IATA Cargo: Not dangerous goods IATA Passenger: Not dangerous goods IMDG-Code: Not dangerous goods

15. Regulatory Information

Additional advice: Classification and labelling according to Directive 67/548/EEC. R-phrase(s) R36: Irritating to eyes.S-phrase(s) S26: In case of contact with eyes, rinse immediately with plenty of water and seek medicaladvice.National legislationWater contaminating class (Germany): WGK 1: slightly water endangeringPoison class (Switzerland): GK 4

16. Other Information

This advice is given by Cambridge Commodities Ltd who accepts no legal liability for it. The information contained herein is based on the present state of our knowledge and is intended to describe our products from the point of view of safety requirements. It should not therefore be construed as guaranteeing specific properties. Individuals working with chemicals should consider all chemicals to be potentially hazardous even if their individual hazards may be uncharacterised or unknown.

This Information provided in this document is subject to change and the batch specific Certificate of Analysis should always be referenced.

To be used as per local legislation.

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Product Code: P22101 Version: 5 Page 15 of 15

Change History

Version Change Customer Notification required Yes / No

1 First Issue N/A

2 Kosher logo has been added. Vegan/Vegetarian Status has been added. Production Flow Chart has been added. Source Material has been changed from 2-Cyanopyridine to 3-Cyanopyridine to correct a clerical error. MSDS has been updated.

Yes

3 Particle size has been updated from 100% through 80 Mesh to > 90% through 120 Mesh to clarify the product specification.

Yes

4 Shelf Life from Date of Manufacture has been updated from 3 Years to Min 3 Years, due to the supplier updating their specification.

No

5 Heavy metal parameters were added, the loss on drying was increased, also the allergen and additive tables were reformatted.

Yes

Document Approval

Originator Job Title Quality Specialist Approver Job Title Quality Specialist

Lucia Valle (Feb 16, 2018)

Page 16: PRODUCT TECHNICAL DOSSIER VITAMIN B3 (NICOTINIC … · PRODUCT TECHNICAL DOSSIER VITAMIN B3 (NICOTINIC ACID) Product Code: P22101 Raw Material Full Name: Pyridine-3-Carboxylic Acid

P22101-Vitamin B3 (NicotinicAcid)-Technical Dossier (2)Adobe Sign Document History 02/16/2018

Created: 02/16/2018

By: Lucia Valle ([email protected])

Status: Signed

Transaction ID: CBJCHBCAABAAC6mltosqFjZEwTtNmSyRQhXRMZ5paKPd

"P22101-Vitamin B3 (Nicotinic Acid)-Technical Dossier (2)" History

Document uploaded by Lucia Valle ([email protected]) from Acrobat02/16/2018 - 3:40:15 AM PST- IP address: 81.145.42.226

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Document viewed by Matthew Vincent ([email protected])02/16/2018 - 3:48:47 AM PST- IP address: 5.178.103.139

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