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Clarithromycin
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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 | 8.8 |
Water | ≤2.0% | 0.72% |
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 |
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
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