Manganese gluconate CAS NO.6485-39-8

Analytical Specifications for Manganese Gluconate (Anhydrous /Dihydrate) USP/FCC Tests Requirements Description : White to off – white or slightly pink coloured granular powder …

Analytical Specifications for Manganese Gluconate (Anhydrous /Dihydrate) USP/FCC Tests Requirements Description : White to off – white or slightly pink coloured granular powder Solubility : Soluble in water, freely soluble in boiling water Identification Manganese TLC : : Shall pass the test Shall pass the test Water content : Between 3 .0% and 9.0 % (Anhydrous) Between 6.0 % and 9.0% (dihydrate) Chloride : Max.0.05 % Sulfate : Max.0.2% (in house - max 0.1%) Lead : Max.2 mg / kg (2 ppm) Heavy metals : Max.20 ppm Reducing Substances : Max.1.0% Organic volatile impurities : Shall meet the requirements Residual solvents : Shall meet the requirements Assay as C12 H22MnO14 ( on anhydrous basis) : 98.0% -102.0% Arsenic : Max. 3 mg / kg (3 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 Nearly colourless to slightly pink colour Manganese content (on as is basis) 10.98 % - 12.22% (AH form) 11.35 % - 12.22% (DH form) pH (5% solution) App.6.5 Mercury Max. 1 ppm Particle Size Distribution Passing thru’ U.S 16 # More than 80 % 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 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