China Azithromycin CAS No. 83905-01-5, Find details about China 83905-01-5, Azithromycin from Azithromycin CAS No. 83905-01-5
| Items | Standard | |
| Characters | White or almost white powder | |
| Solubility | Practically insoluble in water,freely soluble in anhydrous ethanol and in methylene chloride | |
| Identification | A)IR:Conforms to azithromycin RS B)Rt HPLC:Conforms to azithromycin RS | |
| Crystallinity | Exhibit birefringence and extinction positions | |
| PH | 9.0~11.0 | |
| Optical Rotation | -45°~-49° | |
| Water | 4.0%~5.0% | |
| Residue on ignition | ≤0.3% | |
| Limit of related substances | Azithromycin-N-oxide | ≤0.5% |
| 3'-(N,N-didemethyl)-3-N-formylazithromycin | ≤0.5% | |
| Erythromycin A iminoether | ≤0.5% | |
| 3'-(N,N-didemethyl)azithromycin (arminoazithromycin) | ≤0.5% | |
| Azithromycin related compound F | ≤0.5% | |
| Desosaminylazithromycin | ≤0.3% | |
| 3'-N-{[4-(Acetylamino)phenyl]sulfonyl}-3',3'-didemethylazithromycin | ≤0.15% | |
| N-Demethylazithromycin | ≤0.7% | |
| Erythromycin A oxime | ≤0.5% | |
| Azithromycin C(3"-o-demethylazithromycin) | ≤0.5% | |
| 3'-De(dimethylamino)-3'-oxoazithromycin | ≤0.5% | |
| 3'-N-{[4-(Acetylamino)phenyl]sulfonyl}-3'-demethylazithromycin | ≤0.5% | |
| Azaerythromycin A | ≤0.5% | |
| Azithromycin impurity P | ≤0.2% | |
| 2-Desethyl-2-propylazithromycin | ≤0.5% | |
| 3'-N-Demethyl-3'-N-[(4-methylphenyl)sulfonyl]azithromycin | ≤0.5% | |
| 3-Deoxyazithromycin(azithromycin B) | ≤1.0% | |
| Any individual,unidentified impurity | ≤0.2% | |
| Total impurities | ≤3.0% | |
| Assay | 945~1030μg/mg | |
| Residue solvents | Acetone | ≤3000ppm |
| Ethanol | ≤2000ppm | |
| Chloroform | ≤60ppm | |
| Bulk density | ||
| Tapped density | ||
| Malvern Test | d(0.1) | |
| d(0.5) | ||
| d(0.7) | ||
| d(0.9) | ||
| D[4,3] | ||