Azithromycin
| CAS No.: 83905-01-5 | MF: C38H72N2O12 | Place of Origin: Shanghai China (Mainland) |
| Type: Antidote | Grade Standard: Medicine Grade | Brand Name: ldint |
| Model Number: LD20120403 | Purity: 99% |
| Packaging Detail: | 25kg/drum |
| Delivery Detail: | prompt after th order confirm |
azithromycin
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spec.
Tests | Acceptance Criteria | Results | |
Cha | white or almost white crystalline powder, no order and bitter. Practically insoluble in water, freely soluble in anhydrous ethanol and in methylene chloride | Conforms | |
Identification | (1) IR: Conforms to the Azithromycin RS spectrum (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 obtained in the Assay | Conforms | |
Specific rotation | -45°~-49°(Anhydrous subatance 20mg/ml dehydrated alcohol) | -47° | |
Crystallinity | Meets the requirement | Conforms | |
PH | 9.0~11.0(2mg/ml methanol-water(1:1)) | 10.1 | |
Water | 4.0%~5.0% | 4.3% | |
Residue on Ignition | ≤0.3% | 0.02% | |
Heavy metals | ≤0.0025% | less 0.0025% | |
Related substances (HPLC) | (1) desosaminylazithromycin | ≤0.3% | 0.02% |
N-demethylazithromycin | ≤0.7% | 0.44% | |
(2) Any other impurity | ≤1.0% | 0.84% | |
(3) Total impurity | ≤3.0% | 1.6% | |
Residual solvents | Methylene Clloride | ≤600ppm | Not detected |
Acetone | ≤5000ppm | 1306.5ppm | |
Assay(HPLC) | 945~1030μg/mg (Anhydrous substance) | 966μg/mg | |
Conclusion | Conforms to USP32 specification for Azithromycin | ||