Calcium lactate pentahydrate CAS NO.5743-47-5

Analytical Specifications for Calcium Lactate USP FCC (Pentahydrate) Tests Requirements Description White, practically odorless, granules or powder, somewhat efflorescent. Solub…

Analytical Specifications for Calcium Lactate USP FCC (Pentahydrate) Tests Requirements Description White, practically odorless, granules or powder, somewhat efflorescent. Solubility Soluble in water, Freely soluble in boiling water Identification Shall pass the test Acidity Max 0.45% as Lactic acid Loss on drying ( w/w) Between 22.0 % and 27.0% Volatile fatty acid Shall pass the test Heavy metals Max.0.002% Magnesium and alkali salts Max.1.0% Organic volatile impurities Shall meet the requirements Residual solvents Shall meet the requirements Assay as C6H10CaO6 (Calculated on dried basis) 98.0% - 101.0% Fluoride Max. 0.0015% Lead Max. 2 mg / kg ( 2 ppm) Additional Tests - (In House) Calcium content ( on as is basis) : 13.04 % - 14.51% pH (5% solution) : App.6.5 Particle Size Distribution Passing thru U.S 16 # : More than 80 % w/w Bulk density (Loose) : 400-800 kg/ m3 Microbial Limit Tests: Total viable aerobic count : Max.1000 cfu /g Total fungus : Max.100 cfu / g E.Coli : Absent in 10 g Salmonella : Absent in 10 g Staphylococcus aureus : Absent in 10 g Pseudomonas aeruginosa : Absent in 10 g 1. Method of testing as per USP 29, FCC V as applicable. 2. In - house specs. - Method of testing available on request 3. MSDS - Available on request. Other: Shelf life : 3 years from date of manufacturing. Storage condition : Preserve in a sealed container at temperature between 20-250C. Manufacturing Condition : WHO cGMP approved. Quality Certification : ISO, USFDA, EDQM, cGMP, EU-Compliance, HACCP, KOSHER – StarK PAREVE Status, HALAL & ICH-Q7A. Packaging Units : Products can be supplied in packaging ranging from 20 kgs – 50 kgs Packing : Packing Material options include HDPE Bags Plastic Drums, Fiber Drums, Fiber Kegs, High Resistance Paper Sacks and High Density Carton with inner HDPE liner sealed air tight. Dated : 25th September 2006