Short Description:
CAS Number: 83905-01-5
Molecular Formula: C38H72N2O12
Standard: USP3226USP3232
Package: 25kg/drum
Description:
CAS Number: 83905-01-5
Molecular Formula: C38H72N2O12
Standard: USP3226USP3232
Package: 25kg/drum
| ITEMS | LIMIT |
| Appearance | White or almost white power |
| Solubility | Practically insoluble in water,freely soluble in ethanol and in methylene chloride. |
| Identification | |
| A) IR spectrum | Conforms to azithromycin RS |
| B) Rt HPLC | Conforms to azithromycin RS |
| Specific rotation | Between -45°and -49° |
| Crystallinity | Meets the requirements |
| PH | Between 9.0 and 11.0 |
| Related substances | Desosaminylazithromycin |
| ≤0.3% | |
| N-demethylazithromycin | ≤0.7% |
| Any other individual impurity | ≤1.0% |
| Total impurities | ≤0.3% |
| Water | Between 4.0% and 5.0% |
| Residue on ignition | Not more than 0.3% |
| Heavy metals | Not more than 25 ppm |
| Particle size | >150 μm |
| Assay | Not less than 945μg and not more than 1030μg of azithromycin (C38H72N2O12) per mg, calculated on the anhydrous basis |
| Acetone | Not more than 0.5% |
| Ethanol | Not more than 0.05% |
