| 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 powder | Off-white powder |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Water Content | ≤0.50% | 0.20% |
| Heavy Metals | ≤10ppm | Complies |
| Residue on Ignition | ≤0.20% | 0.08% |
| Residual Solvent | Methanol: ≤5000ppm | Complies |
| Related Substances | Any single impurity: ≤0.10% | 0.06% |
| Total impurities: ≤1.00% | 0.18% | |
| Assay (HPLC basis on drying) |
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 | |
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