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Atorvastatin Calcium USP

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.
UN No:
Molecular Formula:
(C33H35FN2O5)2Ca* 3H2O
Molecular Weight:
1155.36 g/mol


Sr. No. Test Limits
1 Description A white to off white powder.
2 Solubility Soluble to freely soluble in Methanol,
Slightly soluble in alcohol, Insoluble to Very
slightly soluble in Distilled Water, pH 7.4
Phosphate buffer, and Acetonitrile, Insoluble
in aqueous solutions of pH 4 and below.
3 Identification
a. By FTIR The infrared absorption spectrum
of the sample should be concordant to
that of the standard.
b. By AAS The sample solution exhibits a
significant absorption at the calcium
emission line at 422.7nm
4 Water by KF (%, w/w) Between 3.5 to 5.5
5 Enantiomeric Purity
by HPLC Related compound E (%, w/w)
Not more than 0.3
6 Related Substances by HPLC(%, w/w)
a. Atorvastatin Diamino Not more than 0.15
b. Atorvastatin Related compound A Not more than 0.30
c. Atorvastatin Related compound B Not more than 0.30
d. Atorvastatin Related compound C Not more than 0.30
e. Atorvastatin 3-Deoxyhept-2-enoic acid Not more than 0.10
f. Atorvastatin Related compound H Not more than 0.15
g. Atorvastatin Epoxy tetrahydrofuran analog Not more than 0.15
h. Atorvastatin Ethyl ester Not more than 0.15
i. Atorvastatin Related compound D Not more than 0.15
j. Atorvastatin Related compound I Not more than 0.15
k. Any other individual impurity Not more than 0.10
l. Total impurities Not more than 1.00
(Reporting level of impurities: 0.05)
7 Assay by HPLC (%,
w/w) On anhydrous basis)
Between 98.0 to 102.0