Test

Specification

Result

Appearance

White or almost white crystalline powder

Complies

Identification

IR/UR

Complies

Water

Between 3.5% and 5.5%

4.7%

Heavy metals

Not more than 20ppm

<20ppm

Calcium

Between 3.0% and 3.6%

3.5%

Impurities(HPLC)

       Epoxide-Atorvastatin

Atorvastatin lactone

Desfluoro-atorvastatin calcium

Diamine-atorvastatin calcium

Difluoro-atorvastatin calcium

Isomer-atorvastatin calcium

Other individual unknown impurity

Total impurities

Not more than 0.01%

Not more than 0.1%

Not more than 0.3%

Not more than 0.3%

Not more than 0.3%

Not more than 0.3%

Not more than 0.10%

Not more than 1.0%

N.D.

≤0.05%

0.10%

≤0.05%

N.D.

≤0.05%

0.06%

0.21%

Assay by HPLC

98.0%~102.0%

100.5%

Conclusion

Complies with USP33