(3R ,5R )-7-[2-(4-Fluorophenyl)-5-Isopropyl-3-Phenyl-4-(Pheynylcarbamoyl) Pyrrol-1-yl]-3 ,5 -Dihydro heptanoic Acid
Test Item |
Standard |
Description |
white crystalline powder |
Impurity |
Desfluoro Atorvastatin |
≤ 0.3 % |
Atorvastatin lactone |
≤ 1.5% |
Other single unknown Impurity |
≤ 0.25% |
Total Impurity |
≤ 2.0% |
Water (%) |
≤ 3.0 % |
Assay( On dries) HPLC (%) |
98.0 ~ 102.0% |
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