Magnesium gluconate CAS NO.3632-91-5

Analytical Specifications for Magnesium Gluconate USP FCC Tests Requirements Description : A white to off white powder Solubili…

Analytical Specifications for Magnesium Gluconate USP FCC Tests Requirements Description : A white to off white powder Solubility : Soluble in water, freely soluble in boiling water Identification Magnesium TLC : : Shall pass the test Shall pass the test pH (1 in 20) : Between 6.0 and 7.8 Water content : Between 3.0 % and 12.0% Chloride : Max 0.05% Sulfate : Max.0.05% 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 C12H22MgO14 (calculated on the anhydrous basis) : 98.0% -102.0% Lead : Max. 0.5 mg / kg (0.5 ppm) Additional tests (In-house) Mercury Max. 1 ppm Magnesium content ( on as is basis) 5.04% - 5.80% Clarity of 10% w/v solution at 250C Clear to nearly clear Colour of 10% w/v solution at 250C Colourless to nearly colourless Particle Size Distribution passing thru' U.S 80 # More than 90 % w/w Bulk density (Loose) 250-650 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