CHEMICAL NAME: (3R,5S,6E)-7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[N-methyl(n-methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-Heptenoic calcium
Item
Standard
Descripition
White or Yellow powder
Identification
• IR-Spectrum • UV
Water
≤ 0.5 %
Specific rotation
19.0-23.0
Heavy metals
≤ 0.002%
Related substance (HPLC)
Diastereomer
≤ 0.15%
Rosuvastatin Lactone
≤ 0.20%
Diene
≤ 0.10%
Unknown single impurity
Total impurity
≤ 2.0%
Assay ( on dry basis )
98.0-102.0%