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Atorvastatin Calcium IP

Uses: Atorvastatin is a statin medication used to prevent cardiovascular disease in those at high risk and treat abnormal lipid levels. For the prevention of cardiovascular disease, statins are a first-line treatment.
Identifiers
CAS No:
[134523-03-8]
BRN No:
-
UN No:
-
Properties
Molecular Formula:
(C33H35FN2O5)2Ca
Molecular Weight:
1155.36 g/mol

Specifications

Sr. No. Test Limits
1 Description A white to off white powder.
2 Solubility Freely soluble in Methanol, Slightly
soluble in Ethanol (95%), Very slightly
soluble in Water.
3 Identification By FTIR IR spectra of the sample should be concordant
to that of the Atorvastatin Calcium standard.
4 Water by KF (%, w/w) Not more than 6.0
5 Specific Optical Rotation (°)(C=1% solution
in Dimethyl sulfoxide, On anhydrous basis)
Between -6.0 to -12.0
6 Heavy Metals (ppm) Not more than 20
7 Related Substances by HPLC(%, w/w) Any other individual impurity - Not more than 0.5,
Total impurities - Not more than 2.0
8 Assay by HPLC (%,
C,66H68F2N4O10Ca
w/w) On anhydrous basis
Not less than 98.0 to Not more than102.0
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