| Function: | Anti-Cancer |
|---|---|
| Certification: | GMP, FDA, ISO |
| Grade Standard: | Medicine Grade |
| Type: | Chemicals |
| State: | Solid |
| Volatile: | Not Volatile |
| Samples: |
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| Customization: |
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| Items | Standards | Results |
| Appearance | White to off-white crystalline powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | Freely soluble in DMSO(100mg/mL), practically insoluble in water and ethanol. | Complies |
| Melting Point | 181ºC~185ºC | 181.5ºC~184.6ºC |
| Loss on Drying | ≤ 1.00% | 0.28% |
| Residue on Ignition | ≤ 0.10% | 0.07% |
| Heavy Metals | ≤ 10ppm | Complies |
| Residual Solvents | Ethanol: ≤ 5000ppm | ND |
| THF: ≤ 5000ppm | 500ppm | |
| DMF: ≤ 880ppm | 75ppm | |
| Acetonitrile: ≤ 5000ppm | 100ppm | |
| Related Substances | Any single impurity: ≤0.10% | 0.08% |
| Total impurities: ≤0.50% | 0.38% | |
| Assay (HPLC basis on drying) |
99.0%~101.0% | 99.75% |
| Bulk Density | 0.25g/mL~0.40g/mL | Complies |
| 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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