Analytical Specifications for Magnesium Citrate USP (Hydrous) (Granular) Tests Limits (As per USP 29) Description : A white, odourle…
Analytical Specifications for Magnesium Citrate USP (Hydrous) (Granular) Tests Limits (As per USP 29) Description : A white, odourless granules. Identification : Shall pass the tests. pH (5% w/v Suspension in water) : 5.0 to 9.0 Loss on drying (At 135°C for 16 h.) : Max. 29.0% Chlorides : Max. 500 ppm Sulphates : Max. 2000 ppm Arsenic : Max. 3 ppm Heavy Metals : Max. 50 ppm. Iron : Max. 200 ppm. Calcium : Max. 1.0% Organic volatile Impurities : Shall pass the test Assay as Mg (As is basis) : Min. 10.5 % Additional Tests (In–House) Lead : Max. 1 ppm Bulk density (Loose Kg/m3) : 500 to 700 Kg/m3 Particle Size 10 mesh (Retention) 60 mesh (Retention) Max. 10.0 % Min. 60.0 % Microbial Limit Tests: Total aerobic count : Max. 1000 CFU/g Total moulds and yeasts : Max. 100 CFU/g E.Coli : Absent Salmonella : Absent 1. Method of testing as per USP 29 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 20-25oC. 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
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