AZITHROMYCIN USP26
1. AZITHROMYCIN 2. CAS NO.83905-01-5
AZITHROMYCIN
| CHARACTERISTICS | WHITE CRYSTALLINE POWDER | CONFORMS |
| IDENTIFICATION | 1. IR TEST | CONFORMS |
| B. HPLC | CONFORMS | |
| SPECIFIC ROTATION | -45~-49° | - 47.5° |
| CRYSTALLINITY | CONFORMS | CONFORMS |
| PH | 9.0~11.0 | 10.1 |
| WATER | 4.0~5.0% | 4.50% |
| RESIDUE ON IGNITION | ≤0.3% | 0.03% |
| HEAVY METALS | ≤25PPM | < 20PPM |
| ASSAY (HPLC DRIED SUBSTANCE) | 945μg/mg~1030μg/mg | 977.8μg/mg |
| RELATIVE SUBSTANCE | ≤1.0% | CONFORMS |
| 1.DESOSAMINYLAZITHROMYCIN | ≤0.3% | 0.09% |
| N-DEMETHYLAZITHROMYCIN | ≤0.7% | 0.40% |
| 2. ANY OTHER IMPURITY | 0.28% | |
| 3. TOTAL IMPURITY | ≤3.0% | 1.30% |
| RESIDUE SOLVENT | ||
| 1. METHYLENE CHLORIDE | ≤0.06% | <0.06% |
| 2. ACETONE | ≤0.5% | <0.5% |
AZITHROMYCIN USP26
