| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| Batch No. | HF170916 | Quantity | 56.5kgs |
| Mfg. Date | Sep. 16, 2017 | Package | As required |
| Rep. Date | Sep. 19, 2017 | Exp. Date | Sep. 15, 2019 |
| 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 ,with pH dependent aqueous solubility | Complies | |
| Water Content(KF) | ≤ 1.00% | 0.46% | |
| Residue on Ignition | ≤ 0.10% | 0.07% | |
| Heavy Metals | ≤ 20ppm | Complies | |
| Mesylate | 15.20%~18.20% | 16.80% | |
| Related Substances | Maximum single impurity: ≤0.20% | 0.03% | |
| Total impurities: ≤1.00% | 0.10% | ||
| Assay (HPLC basis on drying) |
98.00%~102.00% | 99.93% | |
| 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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