| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| Items | Requirements | Result |
| Appearance | It is white or almost white crystalline powder, slightly hygroscopic. | White crystalline powder |
| Specific Rotation | -45°~-49° | -47° |
| Identification | IR spectrum should meet the requirement. | Conforms |
| LC chromatogram should meet the requirement. | Conforms | |
| PH Value | 9.0~11.0 | 10.2 |
| Crystallinity | Birefringence and extinction positions | Conforms |
| Water | 4.0%~5.0% | 4.6% |
| Residue on Ignition | ≤0.3% | 0.1% |
| Related Substances |
Azaerythromycin A≤0.5% | Not detected |
| 3¨Deoxyazithronnycin (azithromycin B) ≤1.0% | 0.7% | |
| Azithromycin C (3′ ′-O-demethylazithromycin) ≤ 0.5% | Not detected | |
| 3′-(N,N-Didemethyl)azithromycin (aminoazithromycin) ≤0.5% |
Not detected | |
| N-Demethylazithromycin ≤0.7% | Not detected | |
| 2-Desethy1-2propylazithromycin ≤0.5% | 0.2% | |
| Azithromycin impurity P ≤0.2% | Not detected | |
| Azithromycin related compound F ≤0.5% | Not detected | |
| 3′ -N-{[4-(Acetylamino) Phenyl]sulfonyl}-3- didemet hylazithromycin ≤0.5% |
Not detected | |
| Azithromycin N-oxide≤0.5% | Not detected | |
| 3′ -(N,N-Didemethyl)-3′ -N- formylazithromycin ≤0.5% | Not detected | |
| 3′ -De(dimethylamino)-3′ - oxoazithromycin ≤0.5% |
Not detected | |
| Desosaminylazithromycin≤0.3% | Not detected | |
| 3′ -N-Demethy1-3′ -N-[(4- methylphenyl)sulfonyl]azithromycin ≤0.5% |
Not detected | |
| Erythronaycin A iminoether≤0.5% | Not detected | |
| Erythromycin A oxime ≤0.5% | Not detected | |
| 3-N-{[4-(Acetylamino)phenyl]sulfonyl}- 3′ -dedemethylazithromycin ≤0.15% |
Not detected | |
| Any other impurity ≤0.2% | 0.1% | |
| Total impurities ≤3.0% | 1.0% | |
| Residual solvents | Methmol ≤0.3% | 0.0015% |
| Ethmol ≤0.5% | 0.0038% | |
| cetone≤0.5% | 0.1618% | |
| Dich1oromethme≤0.06% | 0.0005% | |
| Benzene ≤0.0002% | Not detected | |
| Methylbenzen e≤0.0892% | 0.0001% | |
| Triethylamin e≤0.032% | Not detected | |
| Assay (HPLC) | 945-1030ug/mg | 995ug/mg |
| Conclusion | The product conforms to USP43 specification for Azithromycin. | |
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