PRODUCT TECHNICAL DOSSIER VITAMIN B3 NICOTINAMIDE Product Code: P2210 Raw Material Full Name: Vitamin B3 Nicotinamide Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: Vitamin B3, Vitamin PP, Niacinamide, Pyridine -3- Carboxyamide. This material is Food Grade: Yes Vegan / Vegetarian Status: Yes Limit/Range/Specification: 98.5% - 101.5% CAS Number: 98-92-0 EC/EINECS Number: 202-713-4 Molecular Formula for the raw material: C6H6N2O Average Molecular weight: 122.13g/mol Solubility in Water: 1g Nicotinamide dissolved in 10ml water Product Code: P2210 Version: 3 Page 1 of 14 Solubility in Alcohol: 1g Nicotinamide dissolved in 10ml Alcohol Particle Size: 100%Pass 40 Meshes 98% Pass 60 Meshes 80% Pass 80 Meshes Bulk Density: 0.5023g/m3 Tapped Density: 0.6218g/m3 pH: 6.0-7.5 Loss on Drying: Max 0.5% Residue on Ignition: Max 0.1% Country of Origin: China/India Country of Origin of the Manufacture: China Base Source/Start Material: 3 – Cyanopyridine Origin of Product – Synthetic, Plant, Mineral, Animal, Fish or Fermented: Synthetic Synthetic: What are the starting materials of the synthesis and their sources? 3 – Cyanopyridine Product Code: P2210 Version: 3 Page 2 of 14 Material is: 100% Compound Ingredients Origin, Function and Percentages: None Shelf Life from Date of Manufacture: 3 Years from date of manufacture Storage Conditions: Store under normal conditions keep away from light. Appearance (Fine/Crystals/Crystalline/Hygroscopic): Crystalline Powder Colour: White to Off White Flavour/Taste: Characteristic Odour: Characteristic Microbiological Test Total Viable Count: Max 1,000cfu/g Yeast & Moulds: Max 100cfu/g E.Coli: Negative in 10g Salmonella: Negative in 25g Product Code: P2210 Version: 3 Page 3 of 14 Heavy Metals Lead (Pb): Max 3ppm Cadmium (Cd): Max 1ppm Pharmacopeia Standard Used: EP, USP, FCC, BP, CP, JP 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. Product Code: P2210 Version: 3 Page 4 of 14 INTOLERANCE DATA If No please give details Free from All Animal Products (Beef, Pork, Poultry or other) Free from Bovine Products or Derivatives by using hormones to increase milk yield in cows Free from Bone Meal Free from Peanuts and Peanut Derivatives (including possible cross contamination) Free from other Nut and Nut Derivatives Free from Nut Derived Oil Free from Sesame Seeds and Sesame Seed Derivatives Free from Poppy Seeds and Poppy Seed Derivatives Free from Sunflower Seeds and Sunflower Seeds Derivatives Free from other Seeds and Seed Derivatives Free from Milk and Milk Derivatives (including lactose) Free from Egg and Egg Derivatives Free from Cereals containing Gluten (wheat / rye / oats / barley/ spelt/ kamut or their hybridised strains) and Derivatives Free from Soya and Soya Derivatives Free from Maize and Maize Derivatives Free from Corn and Corn Derivatives Free from Lupin and Lupin Derivatives Free from Yeast and Yeast Derivatives Free from Cotton Seeds (Flour) and Cotton Seed Derivatives Free from Rice and Rice Derivatives Free from Mustard and Mustard Derivatives Free from Celery or Celery Derivatives Free from Celeriac or Celeriac Derivatives Free from Fruit and Fruit Derivatives Free from Vegetable and Vegetable Derivatives Free from Carrot and Carrot Derivatives Free from Legumes / Pulses Free from Fish and Fish Derivatives Free from Crustaceans / Molluscs and their Derivatives Free from Additives Free from Added Salt Free from Added Sugar Free from Antioxidants Free from Artificial Glutamates Free from Aspartame Free from Azo and Coal Tar Dyes Free from Benzoates (E210 / E219) Free from BHA / BHT (E320 / E321) Free from Caffeine Free from Cinnamon Free from Cocoa Free from Colours (Artificial / Nature Identical / Natural / Smoked) Free from Dextrose Free from Dioxins Product Code: P2210 Version: 3 YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES Page 5 of 14 Free from Ethanol YES INTOLERANCE DATA If No please give details Free from Ethylene Oxide Free from Flavourings (Artificial / Nature Identical / Natural / Smoked) Free from Garlic Free from Gelatine Free from Glutamates (E620 to E625) Free from Histamine Free from Hickory Free from Honey Free from Lactose Free from Latex Free from MSG (Added and Naturally Occurring E621) Free from Nucleotides (E627, E630, E631, E635) Free from Polyols Free from Preservatives Free from Starch Products (Including Maltodextrin) Free from Sorbic Acid (E200, E203) 2 Free from Sulphur Dioxide and Sulphites at levels above 10mg/kg or 10mg/litre expressed as SO Free from Sulphites (E220, E228) Free from Sweeteners Free from Vannillin Suitable for Diabetics Suitable for Coeliacs Suitable for Ovo-Lacto Vegetarians Suitable for Vegans Kosher Certified Halal Certified Product Code: P2210 Version: 3 YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES NO Kosher Certified Not certified Page 6 of 14 PRODUCTION FLOW CHART 3 Cyanopyridine Hydrolysis Purified Water Filter Pressing Decolouration Filter Pressing Crystalization Filtration Sifting Packaging Nicotinamide Product Code: P2210 Version: 3 Page 7 of 14 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". Product Code: P2210 Version: 3 Page 8 of 14 MATERIAL SAFETY DATA SHEET Section 1 Identification of the Substance/Mixture and of the Company/Undertaking Product name: Chemical formula: Synonym: Catalog #: Company: Vitamin B3 Nicotinamide C6H6N2O N/A P2210 Cambridge Commodities Limited Lancaster Way, Ely, Cambridgeshire, CB6 3NX Tel: 01353 667258. Email: [email protected] Section 2 Hazards Identification Irritant Target organs HMIS rating NFPA Rating Irritating to eyes, Respiratory system and skin. Eyes. Kidneys Health: 2* Flammability : 0 Reactivity: 0 Health: 2 Flammability: 0 Reactivity: 0 *Additional chronic hazards present. For additional information on toxicity, please refer to section 11. Section 3 Composition/Information on Ingredients Components Vitamin B3 Nicotinamide % in Product 100 CAS Number 98-92-0 Formula C6H6N2O EINECS Number 202-713-4 Section 4 Emergency and First Aid Measures Eyes Skin Product Code: P2210 in the case of contact immediately flush eyes with copious amounts of water for at least fifteen minutes. In the case of contact, immediately wash skin with soap and copious amounts of water. Version: 3 Page 9 of 14 Swallowing Inhalation If swallowed, wash out mouth with water provided person is conscious. Call a physician. If inhaled remove to the fresh air. If not breathing give artificial respiration. If breathing is difficult give oxygen. Section 5 Fire-fighting measures Flash Point Auto ignition temp: Flammability Extinguishing Media Fire Fighting Instructions Specific Hazard(s) 302°F 150°C Method: Closed cup No Data Available No Data Available Foam, water spray, carbon dioxide, dry chemical powder. Wear a self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. Emits toxic fumes under fire conditions. Section 6 Accidental Release Measures Procedures of personal precaution Cleaning up Methods Wear respirator, chemical safety goggles, rubber boots and heavy rubber gloves. Sweep up, place in a bag and hold for waste disposal. Avoid raising dust. Ventilate area and wash spill site after material pickup is complete. Section 7 Handling and Storage Handling Storage Do not breathe in dust. Avoid contact with eyes, skin, and clothing. Avoid prolonged or repeated exposure. Keep tightly Closed. Section 8 Exposure Controls/Personal Protection Engineering Measures: Respiratory Protection Hand/Body Protection Eye Protection Product Code: P2210 Safety shower and eye bath. Mechanical exhaust required. Government approved respirator. Compatible chemical resistant gloves. Chemical Safety Goggles Version: 3 Page 10 of 14 Section 9 Physical and Chemical Properties Physical state Colour Odour Solubility Sieve Analysis Crystalline Powder White/Off White Characteristic Soluble in both water and alcohol. 100% pass 40 Meshes 98% pass 60 Meshes 80% Pass 80 Meshes Section 10 Stability and Reactivity Chemical Stability Hazardous Polymerisation Incompatibility Hazardous Decomposition Products Stable Product will not undergo hazardous polymerisation. Strong oxidising agents. May form Carbon Dioxide, Carbon Monoxide and Nitrogen oxides. Section 11 Toxicological Information Routes Of Exposure Skin Contact Skin Absorption Eye Contact Inhalation Ingestion Target Organs Signs and symptoms of exposure. Conditions aggravated by exposure Toxicity Data Product Code: P2210 Causes Skin Irritation May be harmful if absorbed through skin Causes Eye irritation May be harmful in inhaled, Material is irritation to mucous membranes and upper respiratory tract. Harmful if swallowed in large amounts Liver. Eyes . Kidneys. Other symptoms of exposure can include anorexia, excessive Salivation, Pupillary Construction, Bronchoconstriction, Respiratory failure. Tightness of the chest, coma, pulmonary, ureter and bladder effects. To the best of our knowledge the chemical, physical and toxicological properties have not been thoroughly investigated. May Produce reversible liver damage Oral Rat Oral Rat Version: 3 Page 11 of 14 Remarks Toxicity Data 3500mg/kg 3500mg/kg LD50 LD50 Subcutaneous Subcutaneous Rat Rat 1680MG/KG 1680MG/KG LD50 LD50 Lungs, Thorax, or Respiration: other changes. Lungs, Thorax, or respiration: other Changes Oral Oral Mouse Mouse 2500Mg/kg 2500Mg/kg LD50 LD50 Intraperitoneal Intraperitoneal Mouse 2050Mg/kg LD50 Subcutaneous Mouse 2GM/KG LD50 Mouse 2050Mg/kg LD50 Subcutaneous Mouse 2GM/KG LD50 Species Dose Cell type Mutation Test Human 10MMOL/L Lymphoycte Sister Chromatid Exchange Rat 20MMOL Liver DNA Inhibition Human 10MMOL/L Lymphoycte Sister Chromatid Exchange Rat 20MMOL Liver DNA Inhibition Species Dose Cell Type Mutation test Rat 25mg/kg Ovary Body fluid Assay Rat 25mg/kg Ovary Body Fluid Assay Chronic Exposure - Mutagen Species Dose Cell Type Mutation Test Product Code: P2210 Version: 3 Page 12 of 14 Species Dose Cell type Mutation Test Hamster 5MMOL/L Ovary Sister Chromatid Exchange Hamster 5MMOL/L Ovary Sister Chromatid Exchange Section 12 Ecological Information Eco-toxicity No Data Available Section 13 Disposal Considerations Waste from residues Dissolve or mix material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Observe all federal, state, and local environmental regulations. Section 14 Transport Information Transport classification Not classified as dangerous for any mode of UK or International transport. Section 15 Regulatory Information European Regulation Safety Statements Symbol of danger Xi Irritant R 36/37/38. May be irritating to respiratory system and skin S 26/36. in case of contact with eyes rinse immediately with plenty of water and seek medical advice. Wear suitable protective clothing Section 16 Other Information Product Code: P2210 Version: 3 Page 13 of 14 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. Change History Version Change 1 2 First Issue Updated format corrected spelling error in title and added Kosher status Clerical error MSDS (Vitamin B3) 3 Customer Notification required Yes / No N/A No No Document Approval Originator Job Title Quality Specialist Assistant Quality Manager Hannah Pritchard (Mar 10, 2016) Lucia Valle (Mar 9, 2016) Product Code: P2210 Approver Job Title Version: 3 Page 14 of 14 P2210-Vitamin B3 Nicotinamide-Technical Dossier Adobe Document Cloud Document History 3/10/16 Created: 3/9/16 By: Hannah Pritchard ([email protected]) Status: SIGNED Transaction ID: CBJCHBCAABAAB63kkQdtP7_SM7k9PyW5guKsYyB5082m “P2210-Vitamin B3 Nicotinamide-Technical Dossier” History Document uploaded by Hannah Pritchard ([email protected]) from Reader 3/9/16 - 5:58:18 PST - IP address: 81.145.42.226 Document emailed to Lucia Valle ([email protected]) for signature 3/9/16 - 5:58:21 PST Document viewed by Lucia Valle ([email protected]) 3/9/16 - 6:31:59 PST - IP address: 81.145.42.226 Document e-signed by Lucia Valle ([email protected]) Signature Date: 3/9/16 - 6:32:23 PST - Time Source: server - IP address: 81.145.42.226 Document emailed to Hannah Pritchard ([email protected]) for signature 3/9/16 - 6:32:24 PST Document viewed by Hannah Pritchard ([email protected]) 3/10/16 - 4:52:12 PST - IP address: 81.145.42.226 Document e-signed by Hannah Pritchard ([email protected]) Signature Date: 3/10/16 - 4:52:33 PST - Time Source: server - IP address: 81.145.42.226 Signed document emailed to Hannah Pritchard ([email protected]) and Lucia Valle ([email protected]) 3/10/16 - 4:52:33 PST
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