Calcium D-saccharate tetrahydrate CAS NO.5793-89-5

Analytical Specifications for Calcium D-Saccharate Tests Limits (As per USP 29) Description : A white powder, odourless. Identi…

Analytical Specifications for Calcium D-Saccharate Tests Limits (As per USP 29) Description : A white powder, odourless. Identification : Shall pass the test. Specific optical rotation : + 18.5o to 22.5o Chloride : Max. 0.07 % Sulphate : Max. 0.12 % Heavy Metals : Max. 20 ppm Sucrose / Reducing sugar : Shall pass the test. Organic Volatile impurities : Shall pass the test Assay : 98.5 % - 102.0 % Additional Tests (In–House) Mineral Content 12.0 % – 12.5 % Lead Max. 5 ppm Arsenic Max. 3 ppm Bulk density (Loose Kg/m3) 400– 600 Kg/m3 Particle Size # 40 mesh (US) (pass through) Minimum 99.0 % Microbial Limit Tests: Total plate count : Max. 1000/g Yeasts and Moulds : Max. 100/g Staphylococcus aureus : Absent E. Coli : Absent Bacterial Endotoxin : 320 EU/g 1. Method of testing 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