| Items | Standards | Results |
| Appearance | White or off-white crystalline powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | Very soluble in water,soluble in methanol and alcohol, insoluble in chloroform | Complies |
| Optical Rotation | -30.7°~-32.6° | -31.1°~-32.4° |
| Water Content | ≤ 1.00% | 0.46% |
| Heavy Metals | ≤ 10ppm | Complies |
| Residue on Ignition | ≤ 0.10% | 0.06% |
| Residual Solvents | Acetonitrile: ≤410ppm | ND |
| Ethanol: ≤5000ppm | ND | |
| Related Substances | Oseltamivir acid: ≤0.30% | 0.14% |
| Single maximum unknown impurity: ≤0.10% | 0.06% | |
| Total Impurities: ≤1.00% | 0.52% | |
| Assay (on the anhydrous basis) | 98.0%~102.0% | 99.82% |
| Reference Standard | In-house Standard | |
| Conclusion | The product complied to In-house standard. | |
| Storage | Preserve in tight,light-resistant containers in a cool place | |
Группа Продуктов : API & Intermediates
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