| Function: | Pharmaceutical Medicine |
|---|---|
| Certification: | GMP, FDA, ISO |
| Grade Standard: | Medicine Grade |
| Type: | Chemicals |
| State: | Solid |
| Volatile: | Not Volatile |
| Samples: |
|---|
| Customization: |
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| Items | Standards | Results |
| Appearance | White to light-yellow solid powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | Soluble in DMSO, slightly soluble in water and ethanol, practically insoluble in methanol and DMF | Complies |
| Loss on Drying | ≤ 1.00% | 0.45% |
| Heavy Metal | ≤ 20ppm | Complies |
| Residue on Ignition | ≤ 0.20% | 0.08% |
| Related Substance | Any single impurity: ≤0.50% | 0.15% |
| Total Impurities: ≤1.00% | 0.38% | |
| Assay | 99.0%~101.0% on anhydrous basis | 99.75% |
| Bulk Density | 0.45g/ml~0.70 g/ml | Complies |
| 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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