Magnesium oratate CAS NO.34717-03-8

Analytical Specifications for Magnesium Orotate (Dihydrate) Tests Limits (As per DAC) Appearance : A white to almost white crystalli…

Analytical Specifications for Magnesium Orotate (Dihydrate) Tests Limits (As per DAC) Appearance : A white to almost white crystalline powder. Solubility : Hardly soluble in water. Practically insoluble in 96 % ethanol and ether. Identification IR Magnesium : : Shall pass the IR Spectrum. Shall pass the test. Acidity or Alkalinity test: 1.5g of substance suspended in 30ml of water, stir for 5 minutes and filtered. : 10 ml of the filtrate solution should not consume more than 0.25 ml of 0.01 M HCl solution (or) 10 ml of filtrate solution should not consume more than 0.5 ml of 0.01 N NaOH solution. Specific Absorbance : A1cm (1.0%) 298 - 318 at 285nm. Amino acid test on 1g sample : Shall be absent. Sulphate : Maximum 200 ppm. Heavy Metals : Maximum 20 ppm. Related substances. Hydantonitrile : Not more than 0.1% Assay (by Complexometric titration) : 98.0 % to 101.0 % Additional Tests Lead : Max. 5 ppm Arsenic : Max. 3 ppm pH : 5.0 to 7.0 Mineral Content : 6.3% - 6.5 % Bulk density (Loose Kg/m3) : 400 to 500 Kg/m3 Particle Size # 40 mesh (US) (pass through) : Minimum 80.0 % 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 DAC 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