| Certification: | GMP, FDA |
|---|---|
| Grade Standard: | Medicine Grade |
| State: | Solid |
| Volatile: | Not Volatile |
| Color: | White to Slight Yellow Solid Powder |
| Assay: | More Than 99% |
| Samples: |
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| Customization: |
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| Items | Standards | Results |
| Appearance | White to slight yellow solid powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | Free soluble in methanol,soluble in dimethyl sulfoxide and shows pH dependent solubility in aqueous media. | Complies |
| Loss on Drying | ≤ 3.00% | 1.90% |
| Heavy Metal | ≤ 20ppm | Complies |
| Residue on Ignition | ≤ 0.20% | 0.08% |
| Residual Solvents | Ethanol: ≤ 5000ppm | ND |
| Methanol: ≤ 3000ppm | ND | |
| N.N-Dimethylformamide: ≤ 880ppm | ND | |
| Ethyl acetate: ≤ 5000ppm | 800ppm | |
| Related Substances | Max individual impurity: ≤0.30% | 0.13% |
| Total Impurities: ≤1.00% | 0.85% | |
| Assay (HPLC basis on drying) |
98.0%~102.0% | 99.22% |
| 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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