CLARITHROMYCIN
1. CLARITHROMYCIN 2. CAS NO.81103-11-9 3. Package:25kg/drum 4. USP28
CLARITHROMYCIN
| TESTS | USP Specifications | Results |
| Appearance | White or almost white crystalline powder, No odor and bitter.Insoluble in water, freely soluble in chloroform, soluble in acetone or ethyl acetate, sparingly soluble in methanol of alcohol. | Conforms |
| Identification Tests (IR) | Conforms to the reference spectrum | Conforms |
| Specific optical rotation | -89°-95° | -92° |
| Crystallinity | Should conform to requirements | Conforms |
| PH | Between 7.5 and 10.0 | 8.7 |
| Water | ≤2.0% | 0.92% |
| Residue on ignition | ≤0.3% | 0.04% |
| Residual Solvents | Ethanol≤0.5% | Not detected |
| Heavy metals | ≤20ppm | <20ppm |
| Assay (HPLC, dried substance) | 9601040ug/mg | 981ug/mg |
| Conclusion: Conforms to USP 28 specification for Clarithromycin | ||
CLARITHROMYCIN
