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Ketoconazole
| ITEMS | LIMIT |
| Appearance | White or almost white crystalline powder |
| Packaging and storage | Preserve in well-closed containers |
| Identification | IR test |
| Specific rotation | -1°~ +1° |
| Melting range | 148℃~152℃ |
| Loss on drying | ≤0.5% |
| Residue on ignition | ≤0.1% |
| Heavy metals | ≤0.002% |
| Chromatographic purity | Meets the requirements |
| Residual Solvents | |
| Ethyl acetate | ≤0.5% |
| Assay | 98.0%～102.0％ |
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