Copper gluconate CAS NO.527-09-3

Analytical Specifications for Copper Gluconate USP Tests Requirements Description : Blue or bluish green or greenish blue powder. …

Analytical Specifications for Copper Gluconate USP Tests Requirements Description : Blue or bluish green or greenish blue powder. Solubility : Soluble in water Identification : Shall pass the test Chloride : Max.0.07% Sulphate : Max.0.05% Arsenic : Max.3 ppm Lead : Max.0.0025% Reducing substances : Max.1.0% Residual solvents : Shall meet the requirements Assay as C12H22CuO14 : 98.0% -102.0% Additional tests (In-house) Clarity of 5% w/v solution at 250C Clear to nearly clear Colour of 5% w/v solution at 250C Very slight blue/ Bluish green / greenish blue colour Copper content (on as is basis) 13.72%- 14.28% pH (1% solution) App.4.0 Particle Size Distribution Passing thru’ U.S # 35 More than 90 % w/w Bulk density (Loose) 500– 900 kg/ m3 Microbial Limit Tests: Total viable aerobic count : Max.500 cfu /g Total fungus : Max.50 cfu / g Enterobacteriaceae : Absent in 1g E.Coli : Absent in 10 g Salmonella : Absent in 50 g Pseudomonas aeruginosa : Absent in 10 g Staphylococcus aureus : Absent in 10 gm 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