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Atorvastatin Calcium
| ITEMS | LIMIT |
| Appearance | A white or almost white amorphous powder |
| Identification | Positive reaction |
| Solubility | Complies |
| Water | NMT 3.0% |
| Ca | 2.8 ~ 3.8 |
| Heavy Metals | NMT 10ug/g |
| Total impurity | NMT 2.0% |
| Individual known | Atorvastatin amide NMT 0.2% |
| Desfluoroatorvastatin NMT 0.2% | |
| Diastereisomer NMT 0.2% | |
| Atorvastatin Lactone NMT 0.2% | |
| Individual unknown | NMT 0.1% |
| Residual solvents | Methanol NMT 3000ppm |
| n-hexane NMT 290ppm | |
| Assay | 98.0 ~ 102.0% |
Regulate blood fat, anti-atherosclerosis drugs
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