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CAS NO.83905-01-5
99%(1-25)Kilogram
Description
Azithromycin is an azalide antibiotic, which inhibits the growth of gram negative bacteria, such as Haemophilus influenza.
Azithromycin functions by interfering with 50S ribosomal subunit formation and translation, which inhibits the formation of
proteins essential for bacterial survival. Studies involving capillary electrophoresis suggest that Azithromycin can be used as a
chiral selector for enantiomeric separation of compounds. In addition, Azithrmycin can be used to increase chloride efflux and
selectively reduces tumor necrosis factor α in human cystic fibrosis cells. Furthermore, Azithromycin reduces LPS-induced
pulmonary neutrophilia in mice, via suppressing the expression of IL-1β.
Specification
| Items | Specifications | Results |
| Appearance | White or almost white powder | White powder |
| Solubility | Practically insoluble in water, freely soluble in anhydrous ethanol and in methylene chloride | Conforms |
| Idetification | 1) IR: Conforms to the spectrum of Azithromycin RS | Conforms |
| 2) HPLC: The retention time of azithromycin peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the Standard preparation, as ovtained in the assay | ||
| Specific rotation | -45°~ -49° | -47° |
| Crystallinity | Meets the requirements | Conforms |
| pH | 9.0~11.0 (2mg/ml methanol-water(1:1)) | 10.1 |
| Water | 4.0%~5.0% | 4.60% |
| Residue on ignition | ≤0.3% | 0.01% |
| Heavy metals | ≤25ppm | <25ppm |
| Impurity A ≤0.5% | Not detected | |
| Impurity B ≤1.0% | 0.40% | |
| Impurity C ≤0.5% | 0.22% | |
| Impurity J ≤0.3% | 0.11% | |
| Impurity E ≤0.5% | Not detected | |
| Impurity F ≤0.5% | <0.10% | |
| Impurity G ≤0.5% | Not detected | |
| Related Substances(HPLC Test 2) | Impurity I ≤0.7% | Not detected |
| Impurity L≤0.5% | Not detected | |
| Impurity M≤0.5% | Not detected | |
| Impurity N ≤0.5% | Not detected | |
| Impurity O≤0.5% | 0.11% | |
| Impurity P ≤0.2% | <0.10% | |
| Any other impuirty ≤0.2% | <0.10% | |
| Total impurities ≤3.0% | 0.84% | |
| Residual Solvents | Methylene Chlorde≤600ppm | Not detected |
| Acetone ≤5000ppm | 330ppm | |
| Assay | 945~1030μg/mg (Anhydrous substance ) | 978μg/mg |
| Conclusion | The results can conforms with the USP37 standard. | |
