Calcium levulinate dihydrate CAS NO.5743-49-7

Analytical Specifications for Calcium Levulinate USP (Dihydrate) Oral grade Tests Limits (As per USP 29) Description : A White Powder…

Analytical Specifications for Calcium Levulinate USP (Dihydrate) Oral grade Tests Limits (As per USP 29) Description : A White Powder. Identification : Shall pass the test. Melting range : Between 1190C and 1250C pH (1 in 10) : Between 7.0 and 8.5 Chloride : Max. 700 ppm Sulphate : Max. 500 ppm Heavy metals : Max. 20 ppm Reducing sugars : Shall pass the test. Loss on drying Between 10.5 % to 12.0 % Organic volatile impurities : Shall pass the test. Assay (On dried basis) : 97.5 % to 100.50 % Additional Tests (In-House) Mineral Content : 12.7 % to 13.0 % Lead : Max. 5 ppm Arsenic : Max. 3 ppm Bulk density (Loose Kg/m3) : 500 to 600 Kg/m3 Particle Size # 40 mesh (US) (pass through) : Minimum 90.0 % 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 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