| 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 or off-white crystalline powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | Sparingly soluble in methanol, slightly soluble in acetonitrile and ethanol, very slightly soluble in water | Complies |
| Loss on Drying | ≤ 1.00% | 0.35% |
| Heavy Metals | ≤ 20ppm | Complies |
| Residue on Ignition | ≤ 0.10% | 0.06% |
| Residual Solvents | Ethanol: ≤ 5000ppm | 180ppm |
| Dichloromethane: ≤ 600ppm | 3ppm | |
| Related Substance | Any single impurity: ≤0.10% | 0.06% |
| Total Impurities: ≤1.00% | 0.18% | |
| Assay (HPLC basis on drying) |
98.0%~102.0% | 99.96% |
| 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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