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Home Active Pharmaceutical Ingredients atorvastatin calcium
Product Name : Atorvastatin Calcium BP/EP/USP
Chemical Name : c[(3R,5R)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isoprotopyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt]
CAS Number : 134523-00-5
Chemical Formula : C33H35FN2O5
Molecular Mass : 558.64 g/mol
Therapeutic Category : Hypercholesterolmia

Test Specification
Description A white to off white crystalline powder
Identification The infra-red absorbance spectrum should be concordant with the reference spectrum
Solubility Freely soluble in methanol, slightly soluble in ethanol
Heavy Metals NMT 20 ppm
Assay on dried basis by HPLC NLT 98.0% AND NMT 102.0%
Optical Rotation Between -6.0°and -12.0°on anhydrous basis
Water Content by KF Between 3.0 and 7.0% w/w
Related Substances by HPLC

NMT 0.5%

NMT 2.0%

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