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Simvastatin
| ITEMS | LIMIT |
| Characteristic | A white to off-white crystalline powder |
| Identification | IR: Meet the requirement |
| HPL: Meet the requirement | |
| Solubility | Meet the requirement |
| Specific optical rotation | +285°~ + 298° |
| Heavy Metals | NMT 0.002% |
| Loss on drying | NMT 0.5% |
| Chromatographic purity | Simvastatin hydroxyacid NMT 0.4% |
| Methylene simvastatin NMT 0.4% | |
| Acetyl simvastatin NMT 0.4% | |
| Simvastatin dimer NMT 0.4 | |
| Any other individual impurity NMT 0.1% | |
| Lovastatin and epilovastatin NMT 1.0% | |
| Total impurities (except Lovastatin & epilovastatin) NMT 1.0% | |
| Residue on ignition | NMT 0.1% |
| Residual solvents | Dichloromethane NMT 600ppm |
| Alcohol NMT 5000ppm | |
| Assay (on dried basis) | 98.0 ~ 102.0% |
With lower cholesterol, low-density lipoprotein cholesterol and very low density lipoprotein cholesterol
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