PRODUCT TECHNICAL DOSSIER VITAMIN C DC 97% (ASCORBIC ACID) Product Code: P22155 Raw Material Full Name: Ascorbic Acid 97% Granular Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: L-threo-hex-2-enoic acid Ɣ – lactone This material is Food Grade Limit/Range/Specification: 96% - 98% Ascorbic Acid (Iodine Titration) CAS Number: 50-81-7 EC/EINECS Number: E300 Molecular Formula for the raw material: C6 H8 O6 Average Molecular weight: 176.13 g/mol Solubility in Water: Soluble Solubility in Alcohol: Soluble Particle Size: Min 95% Pass 20 Mesh Max 30% Pass 100 Mesh Product Code: P22155 Version: 2 Page 1 of 13 Bulk Density: ≥0.70g/ml Tapped Density: ≥0.85g/ml Specific Gravity: ≥0.70g/ml pH: 2.1 – 2.6 Loss on Drying: < 0.25% Residue on Ignition: < 0.1% Country of Origin: China Country of Origin of the Manufacture: China Base Source/Start Material: Fermented From Sorbitol (Corn) Origin of Product – Synthetic, Plant, Mineral, Animal, Fish or Fermented: Fermented What is the extraction/processing used? What solvents are used and at what ratio’s? Water Compound Ingredients Origin, Function and Percentages: 2.0% - 4.0% (HPMC) Shelf Life from Date of Manufacture: 3 year Storage Conditions: In closed containers, protected from humidity, at room temperature Product Code: P22155 Version: 2 Page 2 of 13 Appearance (Fine/Crystals/Crystalline/Hygroscopic): Free Flowing Granular Powder Colour: White/Off White/Yellowish Flavour/Taste: Sharp acidic pleasant taste Odour: Almost odourless Microbiological Test Total Viable Count: Max 1,000cfu/g Yeast & Moulds: Max 100cfu/g E.Coli: Negative Salmonella: Negative Staphylococcus: Negative Heavy Metals Heavy Metals: Max 10ppm Arsenic (As): Max 3ppm Pharmacopeia Standard Used: USP/FCC/Ph/Eur Product Code: P22155 Version: 2 Page 3 of 13 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: P22155 Version: 2 Page 4 of 13 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 Product Code: P22155 Version: 2 If No please give details YES YES YES YES YES YES YES YES YES YES YES YES YES YES NO NO Base Starting Material Base Starting Material 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 13 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) 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: P22155 Version: 2 If No please give details YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES NO HPMC 2 – 4% NO NO Not Certified Not Certified Page 6 of 13 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 23rd February 2005 and commission Regulation (EU) No. 559/2011 of 7th June 2011 amending annexes II and III of the above Regulation. Product Code: P22155 Version: 2 Page 7 of 13 MATERIAL SAFETY DATA SHEET 1. Identification of the substance/preparation PRODUCT NAME: VITAMIN C DC 97% (ASCORBIC ACID) PRODUCT CODE: P22155 Supplier: Cambridge Commodities Limited Lancaster Way Business Park, Ely, Cambridgeshire, CB6 3NX. Tel: 01353 667258. Email: [email protected] Section 2 Ingredients/Identity Information Characterization Especially suited for direct compression of tablets Chemical Name L-threo-hex-2-enoic acid Ɣ – lactone; 3-oxo-L-gulofuranolactone (enol form) Synonyms L-ascorbic acid, L-xylo-ascorbic acid, L-(+)-ascorbic acid; Vitamin C CAS Number 50-81-7 Empirical Formula C6H8O6 Molecular Mass 176.13 g/mol Section 3 Possible Hazards Most Important Hazards No particular hazards known Section 4 Emergency and First Aid Procedures Eye Contact Rinse immediately with tap water for 10 minutes – open eyelids forcibly Skin Contact Remove contaminated clothes, wash affected skin with water and soap do not use any solvents Inhalation Remove the causality to fresh air and keep him/her calm in the event of symptoms get medical treatment Product Code: P22155 Version: 2 Page 8 of 13 Note to Physician Treat symptomatically Section 5 Fire and Hazard Data Suitable Extinguishing Media Water spray jet, dry powder, foam, carbon dioxide Specific Hazards Severe dust explosion hazard Protection of Fire-Fighters Precipitate gases/vapours/mists with water spray Section 6 Accidental release measures. Methods for Cleaning Up Collect solids (avoid dust formation) and hand over to waste removal, rinse with plenty of water Section 7 Storage & Handling Handling Technical Measures Processing in closed systems, if possible superposed by inert gas (e.g nitrogen) local exhaust ventilation necessary, take precautionary measures against electrostatic charging avoid dust formation, high dust explosion hazard Suitable Materials Stainless steel, coated steel (protective lacquer), glass, polyethylene, polypropylene, enamel Unsuitable Materials Aluminium, copper, zinc,iron etc Storage Storage Conditions In closed containers, protect from humidity, at room temperature Packing Materials Tightly closed material like polyethylene Section 8 Control Methods/Personal Protection Engineering Measures See Section 7 Threshold Value Air None established Analytics Sampling in water and gravimetric or chemical determination Product Code: P22155 Version: 2 Page 9 of 13 Section 8 Control Methods/Personal Protection - Continued Personal Protective Equipment Respiratory Protection In case of high dust concentrations: particle mask or respirator with independent air supply Skin Protection clothing Wear protective gloves and clean body-covering Eye Protection Safety glasses Section 9 Physical and Chemical Properties Colour Form Odour Section 10 Stability and Reactivity White/Off White/Yellowish Free Flowing Granular Powder Almost odourless Stability humidity Conditions to Avoid Materials to Avoid metal salts Note Stable at room temperature under exclusion of Humidity Oxidising agents, atmospheric oxygen, bases, metals, On prolonged storage, a yellow discolouration may occur through slow decomposition, which does not noticeably diminish biological activity, however in aqueous solutions ascorbic acid is very susceptible to oxidative decomposition, particularly in the presence of alkali resp. Heavy metal irons Section 11 Toxicological Information Acute Toxicity LD50 11’900 mg/kg (oral, rat) LD50 8’000 mg/kg (oral, mouse) LD50 518 mg/kg (i.v.,mouse) Local Effects Eye: may cause mild irritations Mucous membranes: may cause mild irritations Skin: may cause mild irritations; particularly in with humidity (perspiration) conjunction Product Code: P22155 Version: 2 Page 10 of 13 Chronic Toxicity calculum In predisposed individuals 4-12 g/d may cause urinary Mutagenicity Carcinogenicity (several species) Reproduction Toxicity No suspicion of human mutagenicity Not carcinogenic Note Oral uptake of up to 9g per day does not produce any toxic effects, however even lesser quantities may cause diarrhoea. RDA (recommended daily allowance): 60mg Not teratogenic, not embryo toxic Section 12 Ecological Information Inherent Biodegradability Ecotoxicity Air Polution Well inherently biodegradable 97%, 5 d 100%, 15 d (Zahn-Wellens test, OECD No. 302 B) Barely toxic for fish (rainbow trout) LC50 (96h) 1020 mg/l (OECD No. 203) The inhibitory concentration relates to re-attachment to substrate (Dreissena polymorpha), MIC (48h) > 50 mg/l (nominal concentration) Observe local/national regulations Section 13 Disposal Considerations Waste from residues Observe local/national regulations regarding waste disposal. Drain very small quantities into waste water treatment plant. Large amounts incinerate in a qualified installation with flue gas scrubbing Section 14 Transport Information Transport classification Product Code: P22155 Not classified as dangerous for any mode of UK or International transport. Version: 2 Page 11 of 13 Section 15 Regulatory Information European Regulation regulations. This product is not classified according to the EU Reviews, Standards and Regulations Health & Safety at work act 1974. 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: P22155 Version: 2 Page 12 of 13 Change History Version Change 1 2 First Issue Iodine titration added as assay test method. Format updated Customer Notification required Yes / No N/A No Document Approval Task Role Name Amended By QC Technician Kelsey Martin 11.08.2015 Approver Quality Technician M Lee 11.08.2015 Product Code: P22155 Version: 2 Sign Date Page 13 of 13
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