PRODUCT TECHNICAL DOSSIER VITAMIN B12 (METHYL COBALAMIN HYDRATE)

Transcription

1 PRODUCT TECHNICAL DOSSIER VITAMIN B12 (METHYL COBALAMIN HYDRATE) Product Code: P13175 Raw Material Full Name: Co α [ α (5,6-Dimethyl-1H-benzoimidazol-l-yl)]- Co β methylcobamide Assay: (On Dried Basis): Min 98.0% CAS Number: EC/EINECS Number: Molecular Formula for the raw material: C 63 H 91 C 0 N 13 O 14 P Average Molecular weight: Solubility in Water: Sparingly Soluble in Water Solubility in Alcohol: Slightly Soluble in Ethanol (99.5) Bulk Density: About 0.6g/ml Tapped Density: About g.ml

2 Loss on Drying: (Karl Fischer) Max 12% Solution Purity: Clear and Red Colour Related Substances (HPLC): -Total Content: Max 2.0% -Max. Related Substances: Max 0.5% Identification (UV): Complied Country of Origin: China Country of Origin of the Manufacture: China Base Source/Start Material: Mecobalamin synthesized by Cyanocobalamin Produced in House Origin of Product Synthetic, Plant, Mineral, Animal, Fish or Fermented: Synthetic Synthetic: What are the starting materials of the synthesis and their sources? Cyanocobalamin Material is: 100% Compound Ingredients: None Shelf Life from Date of Manufacture: 2 Years

3 Storage Conditions: This material is to be stored in a tightly sealed bag/container and to be kept in a cool place away from moisture and direct sunlight Appearance: Hygroscopic Crystalline Powder Colour: Red to Dark Red Flavour/Taste: Characteristic Texture: Crystalline Powder Odour: Characteristic Heavy Metals: Lead: Max 1ppm Mercury: Max 0.1ppm Arsenic: Max 1ppm Cadmium: Max 1ppm

4 Microbiological Test Total Viable Count: Max 500cfu/g Yeast & Moulds: Max 300cfu/g Enterobacteriaceae: Negative Salmonella: Negative E.Coli: Negative Staphylococcus aureus: Negative There are no nuts in this recipe and are no nuts on site, however we cannot guarantee that the raw materials entering the site are nut free.

5 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 Free from Ethanol NO <0.5%

6 INTOLERANCE DATA 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) Free from Sulphur Dioxide and Sulphites at levels above 10mg/kg or 10mg/litre expressed as SO 2 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 NO NO If No please give details

7 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 1999/2/EC and 1000/3/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). 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 23 rd February 2005 and commission Regulation (EU) No. 559/2011 of 7 th June 2011 amending annexes II and III of the above Regulation.

8 PRODUCT FLOW CHART Cyanocobalamin Transformation Crystallization Vacuum filtration Solve the crude crystal Re-crystallization Vacuum filtration Washing methlcobalamin crystal Vacuum filtration Drying Methlcobalamin final product

9 MATERIAL SAFETY DATA SHEET Section 1 Description Product Name: VITAMIN B12 (METHYL COBALAMIN HYDRATE) Product Code: P13175 Supplier: Cambridge Commodities Limited 59 Lancaster Way, Ely, Cambridgeshire, CB6 1NW. Tel: mail@c-c-l.com Section 2 Ingredients/Identity Information Components % in Product CAS Number Formula EINECS Number Methylcobalamin C63H91C0N13O14P N/A Section 3 Hazards identification Hazards Identification Ingestion May cause irritation to eyes, nose, skin and respiratory tract. Seek medical attention according to symptoms. Excessive intake may cause laxative effects. Section 4 Emergency and First Aid Procedures Eyes Rinse with plenty of water for at least 15 minutes while holding eyelids apart. Seek medical attention if discomfort persists. Skin: Swallowing: Inhalation Wash skin with soap and water. Cover skin with an emollient. Seek medical attention if irritation persists. Seek medical attention if symptoms appear. Wash out mouth. Never give anything by mouth to an unconscious person. Remove to fresh air. If breathing is difficult seek medical attention..

10 Section 5 Fire and Hazard Data Fire and Explosion Hazards May be combustible at high temperatures. Thermal decomposition may release toxic oxides. Organic dusts can form explosive mixtures in the air Extinguishing Media Foam, water spray, carbon dioxide, dry chemical powder Fire Fighting Instructions Section 6 Accidental release measures Wear a self-contained breathing apparatus with a full-face piece operated in the positive pressure demand mode. Use chemical resistant personal protective equipment. Equipment should be thoroughly decontaminated after use.. Procedures of personal precaution Wear respirator, chemical safety goggles, rubber boots and gloves. Environmental precautions Cleaning up Methods Section 7 Storage & Handling Handling Avoid run-off into waterways and sewers. 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. Avoid creating dust. Avoid contact with eyes, skin and clothing, avoid breathing dust, and prolonged or repeated exposure. Storage Section 8 Control Methods/Personal Protection Engineering Measures Keep containers tightly closed in a cool and dry place for quality reasons. Protect from humidity and light. Provide sufficient mechanical (general and/or local exhaust) ventilation to maintain exposure below level of overexposure Respiratory Protection Hand/Body Protection Eye Protection Avoid inhalation. 3M Dust respirator No or 9900 is recommended, or a NIOSH/MSHA jointly approved dust respirator Avoid contact and prolonged or repeated exposure. Wear resistant gloves such as rubber. Wash thoroughly after handling. Protective clothing recommended. Wear safety glasses in compliance with OSHA regulations..

11 Section 9 Physical and Chemical Properties Physical state Colour Odour Section 10 Stability and Reactivity Crystalline Powder Dark Red Practically odourless Chemical Stability Stable under conditions mentioned in section 7 Decomposed by light. Incompatibility Section 11 Toxicological Information Can react with oxidising materials. Toxicity Data LD50 (ORAL RAT): 5000mg/kg-1 Not hazardous according to directive 67/548/EEC Carcinogenicity No evidence of carcinogenic properties. See Registry of Toxic Effects of Chemical Substances (RTECS) for complete information Skin Contact Eye Contact Inhalation Ingestion Section 12 Ecological Information Eco-toxicity Air pollution May cause skin irritation Causes eye irritation May be harmful if inhaled, material is irritation to mucous membranes and upper respiratory tract. May be harmful if swallowed IN LARGE AMOUNTS No Data Available Observe local/national regulations Section 13 Disposal Considerations Waste from residues Dispose of in accordance with all applicable local and national regulations.

12 Section 14 Transport Information Transport classification Section 15 Regulatory Information European Regulation Not classified as dangerous for any mode of UK or International transport. Safety phrases S22/24/25 Reviews, Standards and Regulations Health & Safety at work act 1974 COSHH Regulations (1994) EH40 Occupational exposure limits US Federal Regulations Section 16 Other Information Not known This advice is given by Cambridge Commodities Ltd who accept 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. We confirm that the information above is sourced from the original manufacturers/suppliers Specification To be used as per local legislation