Calcium gluconate CAS NO.299-28-5

Analytical Specifications for Calcium Gluconate USP (Injectable grade) (Anhydrous/ Monohydrate) Tests Specifications: Characters : A white crystalline or granular powder. Solubility : Sparing…

Analytical Specifications for Calcium Gluconate USP (Injectable grade) (Anhydrous/ Monohydrate) Tests Specifications: Characters : A white crystalline or granular powder. Solubility : Sparingly (slowly) soluble in water, freely soluble in boiling water Identification TLC Calcium : : Shall pass the test. Shall pass the test. Loss on drying : Max. 3.0 % (Anhydrous) Max. 1.0 % (Monohydrate) Chloride : Max.0.005% Oxalate : Max.0.01% Phosphate : Max.0.01% Sulfate : Max.0.005% Arsenic : Max.3 ppm Heavy metals : Max.0.001% Magnesium and alkali metals : Max.0.4% Iron : Max.5 ppm Reducing substances : Max.1.0% Organic volatile impurities : Shall meet the requirements Residual solvents : Shall meet the requirements Assay as C12 H22 CaO14 (on dried basis) : 98 .0 % -102.0% (Anhydrous) Assay as C12 H22 CaO14H2O : 99.0 % - 101.0% (Monohydrate) Additional tests (In-house) Clarity of 10% w/v solution in boiling water Clear Colour of 10% w/v solution in boiling water Colourless Calcium content (on as is basis) 8.85 % - 9.50% (Anhydrous) 8.85 % - 9.03 % (Monohydrate) pH (5% solution) App.7.0 Lead Max.0.2 ppm Mercury Max. 1 ppm Particle Size Distribution Passing thru’ U.S 16 # More than 70 % w/w Bulk density (Loose) 250 - 600 kg/ m3 Microbial Limit Tests (in- house specs.) Bacterial Endotoxin Max.0.075 EU / mg Total viable aerobic count Max.100 cfu /g Total fungus Max.50 cfu / g Enterobacteriaceae Absent in 1 g E.Coli Absent in 10 g Salmonella Absent in 50 g Staphylococcus aureus Absent in 10 g Pseudomonas aeruginosa Absent in 10 g 1. Method of testing as per USP 29 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