| Customization: | Available |
|---|---|
| Certification: | GMP, FDA |
| Grade Standard: | Medicine Grade |
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| Items | Standards | Results |
| Appearance | Off-white to white crystalline powder | Complies |
| Solubility | Soluble in DMSO, slightly soluble in methanol, water, very slightly soluble in ethanol. | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Melting Point | 200.0ºC~203.0ºC | 201.8ºC~202.5ºC |
| Loss on Drying | ≤0.50% | 0.10% |
| Heavy Metals | ≤20ppm | Complies |
| Residue on Ignition | ≤0.10% | 0.05% |
| Residual Solvents | Methanol: ≤3000ppm | 600ppm |
| Acetonitrile: ≤410ppm | ND | |
| Ethyl acetate: ≤5000ppm | 200ppm | |
| Related Substances | Maximum single impurity: ≤0.10% | 0.05% |
| Total impurities: ≤0.50% | 0.10% | |
| Assay | 98.5%~101.5% | 99.95% |
| 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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