| Customization: | Available |
|---|---|
| Certification: | GMP, FDA |
| Grade Standard: | Medicine Grade |
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| Items | Standards | Results |
| Appearance | An orange to yellow powder | An orange powder |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | Soluble in 0.1mol/L HCl solution, slightly soluble in water and DMF, insoluble methanol, ethanol, acetonitrile, acetone, THF and 0.1mol/L NaOH solution | Complies |
| Loss on Drying | ≤ 1.00% | 0.19% |
| Heavy Metals | ≤ 10ppm | Complies |
| Residue on Ignition | ≤ 0.50% | 0.12% |
| Residual Solvent | Acetone: ≤ 5000ppm | 600ppm |
| DMF: ≤ 880ppm | ND | |
| Related Substances | Impurity A: £ 0.40% | 0.03% |
| Impurity B: £ 0.40% | 0.04% | |
| Impurity C: £0.15% | 0.03% | |
| Impurity E: £0.15% | ND | |
| Any other single impurity: ≤0.10% | Complies | |
| Total Impurities: ≤1.00% | 0.25% | |
| Assay (HPLC basis on drying) |
98.0%~102.0% | 99.85% |
| 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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