
CAS number: 83905-01-5
Molecular formula: C38H72N2O12
molecular weight: 748.98400
Chemical structure:
| PRODUCT NAME | AZITHROMYCIN DIHYDRATE | |
| Self life | 3 years | |
| TEST | SPECIFICATION | Result |
| Characteristics | White or almost white powder | white powder |
| Identification | ||
| A:Infrared Absorption spectrum | Meets the requirement | Meets the requirement |
| B: The retention time | Corresponds to standard preparation | Meets the requirement |
| Tests | ||
| pH | 9.0~11.0 | 10.4 |
| Specific rotation | -45℃~-49℃ | -47℃ |
| Crystallinity | Meets the requirement | Meets the requirement |
| Water | 4.0%~5.0% | 4.6% |
| Residue on ignition | ≤0.3% | 0.04% |
| Heavy metals | ≤0.0025% | <0.0025% |
| Assay | 945μg/mg~1030μg/mg | 965μg/mg |
| Conclusion: | The above product conforms to USP26 |