Calcium citrate tetrahydrate CAS NO.5785-44-4

Analytical Specifications for Calcium Citrate USP (Tetrahydrate) (Granular) Tests Limits (As per USP 29) Description : White, odourless, crystalline powder. Solubility : Sligh…

Analytical Specifications for Calcium Citrate USP (Tetrahydrate) (Granular) Tests Limits (As per USP 29) Description : White, odourless, crystalline powder. Solubility : Slightly soluble in water, freely soluble in 3N hydrochloric acid, insoluble in ethanol (95 %) Identification : Shall pass the test Loss on drying (At 150°C for 4 hrs.) : 10.0 % to 13.3 % Arsenic : Max. 3.0 ppm Fluoride : Max. 0.003 % Acid – Insoluble substances : Max. 0.2 % Heavy metals : Max. 20 ppm Organic volatile impurities : Shall pass the test Assay as Ca3 (C6H5O7)2 (Previously dried at 150oC to constant weight) : 97.5 % to 100.5 % Additional Tests (In–House) Calcium Content (anhydrous) 23.51 % - 24.24 % Calcium Content (tetrahydrate) 20.55 % - 21.18 % Lead Max. 1 ppm Mineral Content 20 % to 21 % Bulk density (Loose Kg/m3) 400 to 500 Kg/m3 Particle Size 10 mesh (Retention) 60 mesh (Retention) Max. 10.0 % Min. 60.0 % Microbial Limit Tests: Total aerobic count : Max. 1000 CFU/g Total moulds and yeasts : Max. 100 CFU/g E.Coli : Absent Salmonella : Absent 1. Method of testing as per USP 29 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 20-25oC. 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