| 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 solid powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Melting Point | 196.0~198.0ºC | Complies |
| Water Content | ≤ 0.50% | 0.13% |
| Loss on Drying | ≤ 0.50% | 0.12% |
| Heavy Metal | ≤ 10ppm | Complies |
| Residue on Ignition | ≤ 0.10% | 0.06% |
| Related Substances | Any single impurity: ≤ 0.10% | 0.04% |
| Total impurities: ≤ 1.00% | 0.06% | |
| Purity(HPLC) | ≥ 99.0% | 99.94% |
| Assay (HPLC basis on drying) |
98.0% ~ 102.0% | 99.98% |
| 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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