| Certification: | GMP, FDA, ISO |
|---|---|
| Grade Standard: | Medicine Grade |
| Type: | Chemicals |
| State: | Solid |
| Volatile: | Not Volatile |
| Appearance: | White or off-White Crystalline Powder |
| Customization: |
|---|
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| Items | Standards | Results |
| Appearance | White or off-white crystalline powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| By UV | Complies | |
| Solubility | Sparingly soluble in methanol,slightly soluble in acetonitrile and ethanol,very slightly soluble in water,practically insoluble in toluene | Complies |
| Melting Point | 151ºC~155ºC | 152.5ºC~153.0ºC |
| Specific Rotation | +18°~+25° | +18.5° |
| Water Content | ≤0.50% | 0.40% |
| Residue on Ignition | ≤0.10% | Complies |
| Heavy Metal | ≤20ppm | Complies |
| Chloride | ≤0.01% | Complies |
| Sulphate | ≤0.02% | Complies |
| Isomers | Impurity B: ≤0.10% | 0.05% |
| Residual Solvents | Methanol: ≤3000ppm | ND |
| Ethanol: ≤5000ppm | 200ppm | |
| Ethyl Ether: ≤5000ppm | ND | |
| Dichloromethane: ≤600ppm | ND | |
| Hexane: ≤290ppm | ND | |
| Ethyl acetate: ≤5000ppm | 3300ppm | |
| Tetrahydrofuran: ≤720ppm | 100ppm | |
| Toluene: ≤890ppm | 100ppm | |
| Benzene: ≤2ppm | ND | |
| Methyl methanesulfonate: ≤600ppm | ND | |
| Ethyl methanesulfonate: ≤600ppm | ND | |
| Related Substance | Impurity A: ≤0.10% | 0.04% |
| Impurity C: ≤0.10% | ND | |
| Impurity D: ≤0.10% | ND | |
| Impurity E: ≤0.10% | ND | |
| Impurity M02: ≤0.10% | ND | |
| Impurity M03: ≤0.10% | ND | |
| Any other single impurity: ≤0.10% | 0.04% | |
| Total Impurities: ≤0.50% | 0.08% | |
| Assay | 98.0%~102.0% On the anhydrous basis | 99.99% |
| Particle Size | D90: ≤20µm | 9.17µm |
| Reference Standard | In-house Standard | |
| Conclusion | The product complied to In-house standard. | |
| Storage | Preserve in tight,light-resistant containers in a cool place | |
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