PRODUCT TECHNICAL DOSSIER ARGININE (L) ALPHA KETOGLUTARATE (2:1) DIHYDRATE
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1 PRODUCT TECHNICAL DOSSIER ARGININE (L) ALPHA KETOGLUTARATE (2:1) DIHYDRATE Product Code: P01200 Raw Material Full Name: Arginine (L) Alpha Ketoglutarate 2:1 dihydrate Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: Arginine (L) Alpha Ketoglutarate 2:1 dihydrate This material is Food Grade Vegan / vegetarian status Not suitable for vegans or vegetarians Limit/Range/Specification: % Specific Rotation of Material: to CAS Number: Molecular Formula for the raw material: C 17H 38N 8O 11 Average Molecular weight: g/mol Solubility in Water: Soluble in water Solubility in Alcohol: Soluble in alcohol Particle Size: mesh Product Code: P01200 Version: 2 Page 1 of 12
2 Percentage passed through: 60 to 100% pass through 100 mesh Loss on Drying Max 1% ph: Country of Origin: China Country of Origin of the Manufacture: China Base Source/Start Material: L-Arginine and alpha ketoglutaric acid Origin of Product Synthetic, Plant, Mineral, Animal, Fish or Fermented: Synthetic Synthetic: What are the starting materials of the synthesis and their sources? L-Arginine (from an animal source) and alpha ketoglutaric acid Material is: 100% Shelf Life from Date of Manufacture: Minimum 2 years (batch specific) Storage Conditions: Store in cool dry conditions from direct sunlight, heat and moisture. Appearance (Fine/Crystals/Crystalline/Hygroscopic): Crystalline powder Colour: White Flavour/Taste: Odourless Product Code: P01200 Version: 2 Page 2 of 12
3 Odour: Odourless Do any of the parameters change in different seasons? No Microbiological Test Total Viable Count: 1000 cfu/g Yeast & Moulds: 100 cfu/g E.Coli: Absent Salmonella: Absent Heavy Metals Lead (Pb): 3 ppm Cadmium (Cd): 1 ppm Mercury (Hg): 0.1 ppm Arsenic (As): 1 ppm 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: P01200 Version: 2 Page 3 of 12
4 ALLERGENS Listed Item Product on Site at If YES, Please Free From Manufacturer Comment YES/NO YES/NO Free from Peanuts and Peanut Derivatives (including possible cross contamination) YES NO N/A Free from other Nut and Nut Derivatives NO N/A 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) YES Free from Sesame Seeds and Sesame Seed Derivatives YES NO N/A Free from other Seeds and Seed Derivatives (Poppy Seeds, Cotton Seeds, Sunflower NO N/A YES Seeds) Free from Milk and Milk Derivatives (including lactose) YES NO N/A Free from Egg and Egg Derivatives YES NO N/A Free from Cereals and Derivatives containing OR POTENTIALLY CONTAMINATED WITH NO N/A YES Gluten (wheat, wheatgrass, faro, freekeh, spelt, kamut, rye, oats, barley, barley grass) Free from Soya and Soya Derivatives YES NO N/A Free from Lupin and Lupin Derivatives YES NO N/A Free from Mustard and Mustard Derivatives YES NO N/A Free from Celery or Celery Derivatives (including Celeriac) YES NO N/A Free from Fish and Fish Derivatives YES NO N/A Free from Molluscs and their Derivatives YES NO N/A Free from Crustaceans and their Derivatives YES NO N/A Free from Sulphur Dioxide and Sulphites (E220, E228) at levels > 10mg/kg or 10mg/litre YES NO N/A Product Code: P01200 Version: 2 Page 4 of 12
5 ADDITIVES / CONTAMINANTS / DIETARY REQUIREMENTS Listed Item Product on Site at If YES, Please Free From Manufacturer Comment YES/NO YES/NO Free from Additives YES NO N/A Free from Antioxidants YES NO N/A Free from Ethylene Oxide YES NO N/A Free from Gelatine YES NO N/A Free from Flavourings (Artificial / Nature Identical / Natural / Smoked) YES NO N/A Free from Maize / Corn and any Derivatives YES NO N/A Free from Legumes / Pulses YES NO N/A Free from Rice and Rice Derivatives YES NO N/A Free from Added Salt YES NO N/A Free from Added Sugar / artificial or natural sweeteners YES NO N/A Free from Aspartame YES NO N/A Free from BHA / BHT (E320 / E321) YES NO N/A Free from Caffeine YES NO N/A Free from Colours (Artificial / Nature Identical / Natural / Smoked) YES NO N/A Free from Dextrose YES NO N/A Free from Dioxins YES NO N/A Free from MSG (Added and Naturally Occurring E621) or Glutamates (E620 to E625) YES NO N/A Free from Nucleotides (E627, E630, E631, E635) YES NO N/A Free from Polyols (sugar alcohols) YES NO N/A Free from Benzoates (E210 / E219) YES NO N/A Free from Sorbic Acid (E200, E203) YES NO N/A Free from any other Preservatives YES NO N/A Free from Ethanol YES NO N/A Free from Honey YES NO N/A Free from Lactose YES NO N/A Free from Yeast and Yeast Derivatives YES NO N/A Free from All Animal Products (Beef, Pork, Poultry or other) and Derivatives (which may Animal source of L- NO YES include growth/yield hormones, antibiotics etc.) arginine Free from Bovine Products or Derivatives (which may include growth/yield hormones, antibiotics etc.) YES NO N/A Product Code: P01200 Version: 2 Page 5 of 12
6 PRODUCTION FLOW CHART Product Code: P01200 Version: 2 Page 6 of 12
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 1999/3/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 nm". Product Code: P01200 Version: 2 Page 7 of 12
8 MATERIAL SAFETY DATA SHEET 1. Identification of the substance/preparation Product name: L-arginine alpha ketoglutarate (2:1) dihydrate Chemical formula: C 17H 38N 8O 11 CAS No Company: Cambridge Commodities Limited Lancaster Way, Ely, Cambridgeshire, CB6 3NX. Tel: qa@c-c-l.com 2. Hazards Identification Apparatus: Eyes, skin, mucous membranes and upper respiratory tract Health hazards acute: May be harmful by inhalation, ingestion/skin absorption. May cause eye and skin irritation. May be irritating to mucous membranes and upper respiratory tract Health hazards chronic: Not specific hazard 3. Composition of ingredients Name: L-arginine alpha ketoglutarate (2:1) dihydrate CAS: Formula: C 17H 38N 8O 11 Molecular weight: g/mol Structure: Product Code: P01200 Version: 2 Page 8 of 12
9 3. First aid measures Inhalation: If inhaled, removed to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention. Ingestion: Immediately flush nonnasality with plenty of water to conscious person. Never give anything by mouth to an unconscious person. Loosen tight clothing such as a collar, tie belt or waistband. Get medical attention if symptoms appear. Skin Contact: In case of contact, immediately flush skin with plenty of water. Removed contaminated clothing and shoes. Cold water may be used. Wash clothing before reuse. Get medical attention. Eye Contact: Check for and remove any contact lenses. In case of contact. Immediately flush eyes with plenty of water for at least 15 minutes. Cold water may be used. Get medical attention. Aggravating Conditions: hospitalising if the symptom is sustained. 4. Fire-fighting measures Flammability of the Product: May be combustible at high temperature. Extinguishing Media: suitable: SMALL FIRE: Use DRY chemical powder LARGE FIRE: Use water spray, fog or foam. Do not use water Hazardous Thermal (de)composition: These products are carbon oxides (CO,C02), nitrogen oxides(no, N02) Special Fire-fighting Procedures: Fire fighters should wear positive pressure self-contained breathing apparatus (SCBA) and full turnout gear. Protection of Fire-fighters: Be sure to use an approved/certified respirator or equivalent. 5. Accidental Release measures Personal Precautions: Splash goggles. Full suit. Boots. Gloves. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product. Small Spill and Leak: Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements. Large Spill and Leak: 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 evacuating through the sanitary system. 6. Handling and Storage Handling: Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate the residue under a fume hood. Ground all equipment containing material. Do not breathe dust. If ingested, seek medical advice immediately and show the container or the label. Storage: Keep container tightly closed. Keep container in a cool, well-ventilated area. Recommended Use: Use original container. Product Code: P01200 Version: 2 Page 9 of 12
10 7. Exposure Controls/Personal Protection Engineering Measures: 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 contaminants below the exposure limit. Hygiene Measures: Wash hands after handling compounds and before eating, smoking using lavatory, and at the end of day. Personal Protective Equipment Skin and body: Lab coat Eyes: Safely glasses 8. Physical and Chemical Properties Appearance: White crystalline powder Odour: Odourless Solubility: Soluble in water and ethanol, practically insoluble in ether Flash Point: Not available Explosive Properties: Risk of explosion of the product in presence of mechanical impact: Not available Risk of explosion of the product in presence of static discharge: Not available 9. Stability and Reactivity Stability: The product is stable Conditions to avoid: Not available Hazardous Decomposition Products: These products are carbon oxides (CO, C02), nitrogen oxides (NO, N02) 10. Toxicological Information Skin irritation: Not available Chronic toxicity: Repeated or prolonged exposure is not known to aggravate medicalcondition. Other Toxic Effects on Humans: No specific information is available in our database regarding the other toxic effects of this material for humans. Carcinogenic Effects: Not available Mutagenic Effects: Not available Reproduction Toxicity: Not available Teratogenic Effects: Not available 11. Ecological Information Ecotoxicity: Not available Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic. Product Code: P01200 Version: 2 Page 10 of 12
11 12. Disposal Considerations Methods of Disposal; Waste of Residues; Contaminated Packaging: Waste must be disposed of in accordance with local environmental control regulations. 14. Transport Information Not regulated as a hazardous material. DOT Classification: Not DOT controlled material (United States) Identification: Not applicable. Special Provisions for Transport: Not applicable. 15. Regulatory Information Regulatory information: Not applicable 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: P01200 Version: 2 Page 11 of 12
12 Change History Version Change Customer Notification required Yes / No 1 First Issue N/A 2 Changed ph from to to conform to the supplier s specification. Updated Format. Yes Document Approval Originator Job Title QC Technician Approver Job Title QC Technician Ash Bean Ash Bean (Jun 10, 2016) Adam Mulcahy Adam Mulcahy (Jun 10, 2016) Product Code: P01200 Version: 2 Page 12 of 12
13 P01200-Arginine (L) Alpha Ketoglutarate (2.1)- DihydrateTechnical dossier Adobe Sign Document History 06/10/2016 Created: 06/10/2016 By: Status: Transaction ID: Ash Bean SIGNED CBJCHBCAABAACF5in9Io86Fo9PQh9cby4UQA7gmDyEsz P01200-Arginine (L) Alpha Ketoglutarate (2.1)- DihydrateTechnical dossier History Document uploaded by Ash Bean from Reader 06/10/2016-5:07:43 PDT - IP address: Document signed in Reader by Ash Bean (ash.bean@c-c-l.com) Signature Date: 06/10/2016-5:08:03 PDT - Time Source: server - IP address: Document ed to Adam Mulcahy (adam.mulcahy@c-c-l.com) for signature 06/10/2016-5:08:03 PDT Document viewed by Adam Mulcahy (adam.mulcahy@c-c-l.com) 06/10/2016-5:34:15 PDT - IP address: Document e-signed by Adam Mulcahy (adam.mulcahy@c-c-l.com) Signature Date: 06/10/2016-5:34:26 PDT - Time Source: server - IP address: Signed document ed to Ash Bean (ash.bean@c-c-l.com) and Adam Mulcahy (adam.mulcahy@c-cl.com) 06/10/2016-5:34:26 PDT
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