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Clarithromycin
| ITEMS | LIMIT |
| Characters | White or almost white crystalline powder. Practically insoluble in water, soluble in acetone and in methylene chloride, slightly soluble in methanol. |
| Identification | |
| IR | Conforms to the Clarithromycin CRS spectrum. |
| Specific rotation | -89°～-95°(Anhydrous substance 10mg /ml chloroform) |
| Crystallinity | Meets the requirements |
| pH | 7.5 ～ 10.0(1g / 500ml water- methanol (19 |
| 1)) | |
| Water | ≤2.0% |
| Residue on Ignition | ≤0.3% |
| Heavy metals | ≤0.002% |
| Residual solvents | Ethanol≤5000ppm |
| Assay | 96.0%～102.0% (Anhydrous substance) |
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