Test Items |
Standard |
|
Character |
A white or almost white crystalline |
|
specific optical rotation |
-7.0~-9.0 |
|
Water % |
3.5~5.5 |
|
Ca % |
3.0~3.6 |
|
Heavy Metals( ppm) |
≤10 |
|
Impurity |
Atorvastatin Lactone |
≤0.1% |
Desfluoro-atorvastatin calcium |
≤0.2% |
|
Diamine -atorvastatin calcium |
≤0.2% |
|
Isomer-atorvastatin calcium |
≤0.1% |
|
Other individual unknown Impurity % |
≤0.15% |
|
Total impurity |
≤1.0% |
|
Assay % |
98.0-102.0 |