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
CAS：134523-03-8
用 途：用于制造降血酯藥
用 途：用于制造降血酯藥
| 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 |
|
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