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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 |
PRODUCTOS POR GRUPO : API e intermedios
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Privacy statement: Your privacy is very important to Us. Our company promises not to disclose your personal information to any external company with out your explicit permission.