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LC1233 Calcium gluconate monohydratesuitable for use as excipient exp Ph Eur,BP,USP,FCC,E 578 Order number Packaging Quantity Price AC28233 Double PE Sack 25 kg inquire Product information Grade Ph Eur,BP,USP,FCC,E 578 Synonyms D-Gluconic acid calcium salt monohydrate Hill Formula C12H22CaO14 * H2O HS Code 2918 16 00 EC number 206-075-8 Molar mass 448.40 g/mol CAS number 66905-23-5 Chemical and physical data Solubility 30 g/l (20 C) Melting point 178 C Molar mass 448.40 g/mol Bulk density 560 kg/m3 pH value 6.4 - 8.0 (50 g/l, H2O, 20 C) Safety information Storage class EW1760000 WGK 10 - 13 Other liquids and solids Disposal 3Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C. Transport information Declaration (transport by sea) IMDG-Code No Dangerous Good Declaration (transport by air) IATA-DGR No Dangerous Good Toxicological data LD 50 oral LD50 rat > 5000 mg/kg Specifications Assay(complexometric) 98.5 - 102.0% Identity - IR-spectrum passes test - TLC passes test - Calcium passes test Appearance white or almost white, crystalline powder Appearance of solution(20g/l, water) passes test pH(50g/l; water) 6.0 - 8.0 Chloride (Cl) 200ppm Sulfate (SO4) 100ppm Oxalate(C2O4) 100ppm Phosphate (PO4) 100ppm Heavy metals(as Pb) 10ppm As (Arsenic) 3ppm Cu (Copper) 25ppm Fe (Iron) 5ppm Pb (Lead) 2ppm Zn (Zinc) 25ppm Magnesium and alkali metals 0.4% Organic substances and boric acid passes test Residual solvents(Ph.Eur./USP/ICH) excluded by manufacturing process Organic volatile impurities(USP/NF) conforms Reducing substances(USP) 1.0% Sucrose and reducing sugars passes test Loss on drying(105C, 16h) 2.0% Microbiological test - Total aerobic microbial count (TAMC) 1000CFU/g - Total combined yeasts/moulds count (TYMC) 100CFU/g - Bile-tolerant gram-negative bacteria (absent in 1 g) passes test - Candida albicans (absent in 1 g) passes test - Escherichia coli (absent in 1 g) passes test - Pseudomonas aeruginosa .br (absent in 1 g) passes test - Salmonella (absent in 10 g) passes test - Staphylococcus aureus .br (absent in 1g) passes test Residues of metal catalysts or metal reagents acc.to EMEA/CHMP/SWP/4446/2000 are not likely to be present. This product is not intended for use in preparing injectable dosage forms.