Calcium orotate CAS NO.22454-86-0

Analytical Specifications for Calcium Orotate (Dihydrate) Tests Limits (As per DAC) Characters : White to almost white crystalline p…

Analytical Specifications for Calcium Orotate (Dihydrate) Tests Limits (As per DAC) Characters : White to almost white crystalline powder. Solubility : Hardly soluble in water. Practically insoluble in 96% ethanol and ether. Identification IR Calcium : : Complies Positive Acidity or Alkalinity test on 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 0.25ml of 0.01M HCl solution (or) 10 ml of filtrate solution should not consume more than 0.5 ml of 0.01N NaOH solution. Specific absorbance : A1cm (1.0%) 286 - 306 at 285nm Amino acid test on 1g sample : Shall be absent. Sulphate : Not more than 200ppm Total Heavy Metals : Not more than 20ppm. Assay by Complexometric titration dried basis : Between 98.0 % to 101.0 % Related substances. Hydantonitrile. : Not more than 0.10% Additional Tests Lead : Max. 5 ppm Arsenic : Max. 3 ppm pH : 5.0 to 7.0 Mineral Content : 10.0 % to 10.5 % Bulk density (Loose Kg/m3) : 400 to 600 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