PRODUCT TECHNICAL DOSSIER L-CARNITINE TARTRATE

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1 PRODUCT TECHNICAL DOSSIER L-CARNITINE TARTRATE Product Code: P0316 Raw Material Full Name: L-Carnitine-L-Tartrate Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: (R)-Bis [(3-carboxy-2-hydroxypropyl) trimethyl Ammonium] L-tartrate This material is Food Grade L-Carnitine: 67.2% % L-Tartaric Acid: 30.8% % Assay: Min 98% CAS Number: Molecular Formula for the raw material: C18H36N2O12 Average Molecular weight: Solubility in Water: Soluble in water Solubility in Alcohol: Slightly soluble in alcohol Product Code: P0316 Version: 2 Page 1 of 13

2 Particle Size: 20 60mesh Percentage passed through: 95% ph: Loss on Drying: Max 0.5% Specific Rotation: -9.5 o o Residue on Ignition: Max 0.5% Melting Range: 169 o C 175 o C Country of Origin: China Country of Origin of the Manufacture: China Base Source/Start Material: Epichlorohydrin Origin of Product Synthetic, Plant, Mineral, Animal, Fish or Fermented: Synthetic Synthetic: What are the starting materials of the synthesis and their sources? Epichlorohydrin Material is: 100% Product Code: P0316 Version: 2 Page 2 of 13

3 Compound Ingredients: None Shelf Life from Date of Manufacture: 2 years Storage Conditions: Cool and dry Appearance: Free flowing crystalline powder Colour: White/off white Flavour/Taste: Characteristic Texture: Crystalline powder Odour: Characteristic Microbiological Test Total Viable Count: Max 1,000cfu/g Yeast & Moulds: Max 100cfu/g E.Coli: Negative Salmonella: Negative Product Code: P0316 Version: 2 Page 3 of 13

4 Metals Heavy Metals: Max 20ppm Lead (Pb): Max 3ppm Arsenic (As): Max 1ppm Cadmium (Cd): Max 1ppm Mercury (Hg): Max 0.1ppm Chloride: Max 0.4% Cyanide: Negative Pharmacopeia Standard Used: CP 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. Please note that surveillance testing may mean that not all the parameters stated on this specification are tested for every batch. Product Code: P0316 Version: 2 Page 4 of 13

5 INTOLERANCE DATA 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 If No please give details Product Code: P0316 Version: 2 Page 5 of 13

6 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) 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 NO Not Certified Halal Certified NO Not Certified Product Code: P0316 Version: 2 Page 6 of 13

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. Product Code: P0316 Version: 2 Page 7 of 13

8 1. Identification of the substance/preparation MATERIAL SAFETY DATA SHEET Product Name: Product Code: Supplier: L-CARNITINE TARTRATE P0316 Cambridge Commodities Limited Lancaster Way, Ely, Cambridgeshire, CB6 3NX. Tel: Section 2 Ingredients/Identity Information Components % in Product CAS Number Formula EINECS Number L-Carnitine-L-Tartrate C18H36N2O12 N/A Section 3 Hazards identification Potential Acute Health Effects Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation Potential Chronic Health Effects Carcinogenic Effects Mutagenic Effects Teratogenic Effects Developmental Toxicity Repeated or prolonged exposure is not known to aggravate medical condition Section 4 Emergency and First Aid Procedures Eye Contact Skin Contact Serious Contact Check and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15minutes. Cold water may be used. Seek medical attention if irritation occurs Wash with soap and water. Cover the irritation skin with an emollient. Seek medical attention if irritation develops. Cold water may be used Product Code: P0316 Version: 2 Page 8 of 13

9 Section 4 Continued Inhalation Serious Inhalation Ingestion Serious Ingestion If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult give oxygen. Seek medical attention. Do NOT induce vomiting unless directed to do so by a medical person. Never give anything by mouth to an unconscious person. If large quantities of this material are swallowed seek medical attention immediately. Loosen tight clothing such as collar, tie, belt or waistband Section 5 Fire and Hazard Data Flammability of the Product Auto-Ignition Temperature Flash Points Flammable Limits Products of Combustion May be combustible at high temperature Fire Fighting Media and Instructions Small Fire Use dry chemical powder Large Fire Use water spray, fog or foam. Do not use water jet Remarks on Fire Hazards As with most organic solids, fire is possible at elevated temperatures Section 6 Accidental release measures Small Spill Large Spill Use appropriate tools to put spilled solid into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate through the sanitary system Product Code: P0316 Version: 2 Page 9 of 13

10 Section 7 Storage & Handling Precautions Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not breath dust Storage Keep container tightly closed. Keep container in a cool, well-ventilated area. Section 8 Control Methods/Personal Protection Engineering Controls Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminates below exposure limit Personal Protection Safety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves Personal Protection in case of a Large Spill Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self-contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product Exposure Limits Section 9 Physical and Chemical Properties Physical state Crystalline Powder Colour White to off white Odour Characteristic Molecular Weight ph Melting Point 169 o C 175 oc Product Code: P0316 Version: 2 Page 10 of 13

11 Section 10 Stability and Reactivity Stability Polymerisation Conditions of Instability Corrosivity Incompatibility The product is stable Will not occur Excess Heat Section 11 Toxicological Information Routes of Entry Toxicity to Animals Acute Oral Toxicity (LD50) Acute Dermal Toxicity (LD50) Chronic Effects on Humans Other Toxic Effects on Humans Inhalation, ingestion Slightly hazardous in case of skin contact (irritation), of ingestion of inhalation Section 12 Ecological Information Eco-toxicity BOD5 and COD Products of Bio Degradation No Data Available Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise Section 13 Disposal Considerations Waste from residues Dispose of in accordance with all applicable local and national regulations. Section 14 Transport Information Transport classification Not classified as dangerous for any mode of UK or International transport. Product Code: P0316 Version: 2 Page 11 of 13

12 Section 15 Regulatory Information European Regulation This product is not classified according to the EU regulations. Reviews, Standards and Regulations Health & Safety at work act COSHH Regulations (1994). EH40 Occupational exposure limits. US Federal Regulations Not known. Section 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. Product Code: P0316 Version: 2 Page 12 of 13

13 Change History Version Change Customer Notification required Yes / No 1 First Issue N/A 2 Format Updated. EU Heavy Metals Limits Added. Yes Document Approval Task Role Name Sign Date Amended By QC Technician Kelsey Martin Approver Quality Technician M Lee Product Code: P0316 Version: 2 Page 13 of 13

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