Atorvastatin Calcium

CAS number: 134523-03-8

Molecular formula: C66H68CaF2N4O10

molecular weight: 1155.34

Chemical structure:

SR.NOTESTSPECIFICATIONRESULT
1DESCRIPTIONWhite to off white crystalline powderWhite crystalline powder
2SolubilityFreely Soluble in methanol , slightly soluble in alcohol, very   slightly soluble in distilled water, in Ph 7.4 phosphate buffer and in   acetonitrile, insoluble in aqueous solution of pH 4 and below.Complies
3IdentificationA.    By IR :The IR spectrum   of sample should be concordant with the IR spectrum of standard.Complies
B.      Calcium : The sample solution exhibits a significant absorption at the   calcium emission line at 422.7 nm.Complies
4Organic impurities by HPLCAtorvastatin related Compound –A : Not more than 0.3%0.09%
Atorvastatin related Compound –B : Not   more than 0.3%Not detected
Atorvastatin related Compound –C : Not   more than 0.3%0.03%
Atorvastatin related Compound –D : Not   more than 0.2%Not detected
Any other individual impurities : Not more   than 0.1%0.10%
Total impurities: Not more than 1.0%0.34%
5Enantiomeric purity by HPLCAtorvastatin related Compound –E : Not more than 0.3%0.04%
6Heavy MetalsNot more than 20 ppmLess than 20 ppm
7Water content by KFRNot less than 3.5% w/w and not more than 5.5% w/w4.26% w/w
8Assay by HPLCNot less than 98.0% w/w and not more than 102.0% w/w (on anhydrous   basis )99.27% w/w
9Residual Solvents by HS- GCMetanol:    Not more than :   3000 ppm29 ppm
Isopropyl alcohol: Not more than : 5000   ppm11 ppm
Acetone: Not more than : 5000 ppm06 ppm
Cyclohexane: Not more than 3880 ppm21 ppm