(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%