China Darunavir Ethanolate CAS: 635728-49-3, Find details about China Darunavir Ethanolate, 635728-49-3 from Darunavir Ethanolate CAS: 635728-49-3
PARAMETER | SPECIFICATION | RESULTS | CONCLUSION |
1. Description | White or off-white crystalline powder | White crystalline powder, odourless | Complies |
2.Identification IR | corresponds to the standard spectrum | corresponds to the standard spectrum | Complies |
3.Optical rotation | -0.5º~ +0.5º | -0.4º | Complies |
4.Related substances ( by HPLC) | Max Single impurity≤0.1% Total impurities≤0.5% | ND | Complies |
5. Water (by K.Fisher) | ≤1.0% | 0.48% | Complies |
6.Residue on ignition | ≤ 0.1% | <0.1% | Complies |
7. Heavy metal | ≤10ppm | <10ppm | Complies |
8.Content of Ethanol(by GC) | ≤ 7.5% | 7.2% | Complies |
9.Residual solvent | Methanol ≤ 0.30% | Methanol 0.10% | Complies |
10. Assay | ≥98.5% | 99.5% | Complies |
CONCLUSION | Qualified |