5-(4-氟苯基)-2-(1-甲基-乙基)-N,4-二聯(lián)苯-1-[2-[(2R,4R)-四氫-羥基-6-氧代-2H-吡喃-2-yl]乙基]-1H-吡咯-3-羧酸胺鹽
-(4-fluorophenyl)-2-(1-methyl-ethyl)-N,4-diphenyl-1-[2-[(2R,4R)-tetrahydro- hydroxy-6-oxo-2H-pyran-2-yl]ethyl]-1H-pyrrole-3-carboxamide
| Test Item |
Standard |
| Description |
white crystalline powder |
| Impurity(HPLC) |
Desfluoro Atorvastatin lactone |
≤ 0.3 % |
| Atorvastatin acid |
≤ 1.0% |
| Atorvastatin Dimer |
≤ 0.3% |
| Other single unknow Impurity |
≤ 2.0% |
| Total Impurity |
≤ 3.0 % |
| Water (%) |
≤ 3.0 % |
| Assay ( On dries) HPLC (%) |
98.0 ～ 102.0% |
| Packing Size |
Less than 1Kg : Foil Bags |
| Less than 20 Kg : Big or small Aluminum barrel or Cartons |
| More than 20 Kg : 25KG/ Bins or Cartons |
| Note |
Powder |
|
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