| Certification: | GMP, FDA, ISO |
|---|---|
| Grade Standard: | Medicine Grade |
| Type: | Chemicals |
| State: | Solid |
| Volatile: | Not Volatile |
| Appearance: | Yellowish Crystalline Powder |
| Customization: |
|---|
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| Items | Standards | Results |
| Appearance | Yellowish crystalline powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Specific Rotation | -9.5°~-11.0° | -10.1° |
| Loss on Drying | ≤0.50% | 0.36% |
| Residue on Ignition | ≤0.10% | 0.04% |
| Heavy Metals | ≤20ppm | Complies |
| Meglumine Content | 30.0%~32.0% | 31.22% |
| Residual Solvent | Ethanol: ≤ 500ppm | Complies |
| Ethyl Acetate: ≤ 500ppm | Complies | |
| TAF: ≤ 72ppm | Complies | |
| Acetone: ≤ 500ppm | Complies | |
| Related Substance | Any single impurity: ≤0.10% | Complies |
| Total Impurities: ≤0.50% | 0.30% | |
| Assay | 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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