China Entecavir Monohydrate 209216-23-9, Find details about China Entecavir Monohydrate, 209216-23-9 from Entecavir Monohydrate 209216-23-9
| Items | Standards | Results |
| Appearance | White or off-white solid powder | White solid powder |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Specific Rotation | +24.0°~+28.0°(DMF:MeOH=1:1 c=1%) | +9.5° |
| pH | 5.5~7.5 | 6.8 |
| Water Content | 5.6%~7.2% | 6.1% |
| Heavy Metal | ≤ 20ppm | Complies |
| Residue on Ignition | ≤ 0.10% | 0.04% |
| Enantiomer | ≤ 0.20% | ND |
| Residual Solvents | Methanol: ≤3000ppm | ND |
| Dichloromethane: ≤600ppm | ND | |
| Tetrahydrofuran: ≤720ppm | ND | |
| Toluene: ≤890ppm | ND | |
| Hexane: ≤290ppm | ND | |
| DMF: ≤880ppm | ND | |
| Related Substances | Any single impurity: ≤0.10% | 0.05% |
| Total Impurities: ≤0.30% | 0.07% | |
| Assay (HPLC basis on drying) | 98.0%~102.0% | 99.90% |
| Reference Standard | In-house Standard | |
| Conclusion | The product complied to In-house standard. | |
| Storage | Preserve in tight,light-resistant containers in a cool place | |