化学名称 :[R,(R ﹡ ,R ﹡ )]-2-(4- 氟苯基 )- β , α - 二羟基 -5-(1- 甲基乙基 )-3- 苯基 -[( 苯胺基 )- 羟基 ]-1H- 吡咯 -1- 庚酸钙盐 (2:1)
L5(Atorvastatins Calcium amorphous ):(3R,5R)-7-[2-(4-Fluorophenyl)-5-Isopropyl-3-Phenyl
-4-(Pheynylcarbamoyl)Pyrrol-1-yl]-3,5-Dihydroheptanoic Acid, calcium salt (2:1) Trihydrate
CAS:134523-03-8
用 途:用于制造降血酯药
用 途:用于制造降血酯药
Test Items |
Standard |
Character |
A white or almost white Amorphous powder |
specific optical rotation |
-7.0~-9.0 |
Water % |
≤0.5 |
Ca % |
3.0-3.6 |
X-RAY Diffraction |
amorphous |
Heavy Metals ( ppm ) |
≤ 10 |
Impurity(HPLC) |
Atorvastatin Lactone |
≤ 0.3% |
Desfluoro-Atorvastatins Calcium |
≤ 0.3% |
Diamine –Atorvastatins Calcium |
≤ 0.3% |
Isomer-Atorvastatins Calcium |
≤ 0.3% |
Other individual unknown Impurity % |
≤ 0.25% |
Total impurity |
≤ 1.0% |
Assay % |
98.0-102.0 |
|