| Customization: | Available |
|---|---|
| Function: | Pharmaceutical Medicine |
| Certification: | GMP, FDA, ISO |
|
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| Items | Standards | Results |
| Appearance | White to light yellow solid powder | Light yellow solid powder |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | Soluble in Dimethylsulfoxide,slightly soluble in Ethanol and Acetonitrile,with pH dependent aqueous solubility | Complies |
| Water Content(KF) | ≤ 1.00% | 0.38% |
| Residue on Ignition | ≤ 0.10% | 0.07% |
| Heavy Metals | ≤ 20ppm | Complies |
| Mesylate | 15.20%~18.20% | 17.20% |
| Residual Solvents | Acetonitrile: ≤410ppm | ND |
| Acetone: ≤5000ppm | 2500ppm | |
| Tetrahydrofuran: ≤720ppm | ND | |
| Related Substances | Maximum single impurity: ≤0.20% | 0.05% |
| Total impurities: ≤1.00% | 0.08% | |
| Assay (HPLC basis on drying) |
98.00%~102.00% | 99.96% |
| Particle Size | D90: ≤100µm | 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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