化學名稱 :[R,(R ﹡ ,R ﹡ )]-2-(4- 氟苯基 )- β , α - 二羥基 -5-(1- 甲基乙基 )-3- 苯基 -[( 苯胺基 )- 羥基 ]-1H- 吡咯 -1- 庚酸鈣鹽 (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
含量：≥98%
CAS：134523-03-8
用途： 用于制造降血酯藥
Test
Items |
Standard |
Character |
A white
or almost white crystalline powder |
specific
optical rotation |
-7.0~-9.0 |
Water
% |
3.5~5.5 |
Ca
% |
3.0~3.6 |
Heavy
Metals ( ppm ) |
≤ 10 |
Impurity (HPLC) |
Atorvastatin Lactone |
≤ 0.1% |
Desfluoro-Atorvastatins Calcium |
≤ 0.2% |
Diamine –Atorvastatins Calcium |
≤ 0.2% |
Isomer-Atorvastatins Calcium |
≤ 0.1% |
Other individual unknown
Impurity % |
≤ 0.15% |
Total impurity |
≤ 1.0% |
Assay
% |
98.0-102.0 |
|
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