Potassium gluconate CAS NO.299-27-4

Analytical Specifications for Potassium Gluconate USP FCC (Anhydrous) Tests Requirements Description : White to off white crystalline or granular powder Solubility : Freely s…

Analytical Specifications for Potassium Gluconate USP FCC (Anhydrous) Tests Requirements Description : White to off white crystalline or granular powder Solubility : Freely soluble in water, Practically insoluble in dehydrated alcohol, in ether. Identification : Shall pass the test Loss on drying : Max. 3.0 % w/w Heavy metals : Max. 0.002% Reducing substances : Max. 1.0% Organic volatile impurities : Shall meet the requirements Residual solvents : Shall meet the requirements Assay as C6H11KO7 (Calculated on the dried basis) : 98.0% - 103.0% Lead : Max. 2 mg / kg ( 2 ppm) Additional tests (In-house) Clarity of 5% w/v solution at 250C Clear to nearly clear Colour of 5% w/v solution at 250C Colourless to nearly colourless Potassium content (on as is basis) 15.86 % - 17.19% pH (5% solution) App.7.0 Mercury Max. 1 ppm Particle Size Distribution Passing thru’ U.S 16 # More than 80 % w/w Bulk density (Loose) 600– 950 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, 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