Zinc gluconate CAS NO.4468-02-4

Analytical Specifications for Zinc Gluconate USP / FCC Tests Requirements Description : A white or practically white powder Sol…

Analytical Specifications for Zinc Gluconate USP / FCC Tests Requirements Description : A white or practically white powder Solubility : Soluble in water, freely soluble in boiling water Identification Zinc TLC : : Shall pass the test Shall pass the test pH (1 in 100) : Between 5.5 and 7.5 Water : Not more than 11.6% Chloride : Max.0.05% Sulfate : Max.0.05% Arsenic : Max.3 ppm Reducing substances Max.1.0% Cadmium : Max. 2 mg / kg (2 ppm) Lead : Max. 1 mg / kg (1 ppm) Organic volatile impurities : Shall meet the requirements Residual solvents : Shall meet the requirements Assay as C12 H22ZnO14 (Calculated on the anhydrous basis) : 97.0 % - 102.0% Additional tests (In-house) Clarity of 10% w/v solution at 250C Clear to nearly clear Colour of 10% w/v solution at 250C Colourless to nearly colourless Zinc content (on as is basis) 12.25%-14.64 % Mercury Max. 1 ppm Particle Size Distribution Passing thru' U.S 80 # More than 90 % w/w Bulk density (Loose) 350 - 700 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 g 1. Method of testing as per USP 29, FCC V 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 20-250C. 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