| Customization: | Available |
|---|---|
| Function: | Antineoplastic, Chemical Medicine Raw Materal |
| Certification: | GMP, USP, Ep, Bp |
|
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| Batch No. | HF171121 | Quantity | 8.5kgs |
| Mfg. Date | Nov. 21, 2017 | Package | As required |
| Rep. Date | Nov. 25, 2017 | Exp. Date | Nov. 20, 2019 |
| Items | Standards | Results | |
| Appearance | White or off-white solid powder | Complies | |
| Identification | By IR | Complies | |
| By HPLC | Complies | ||
| Solubility | Soluble in DMF, sparingly soluble in THF, slightly soluble in methanol and acetonitrile, very sightly soluble in ethanol and dichloromethane, insoluble in water | Complies | |
| Polymorphic Form | Polymorphic form 1 | Complies | |
| Melting Point | 211ºC~216ºC | 212.8ºC~214.9ºC | |
| Water Content | ≤ 0.50% | 0.10% | |
| Heavy Metals | ≤ 20ppm | Complies | |
| Residue on Ignition | ≤ 0.20% | 0.09% | |
| Related Substance | Any single impurity: ≤0.10% | 0.06% | |
| Total Impurities: ≤1.00% | 0.16% | ||
| Assay (on the anhydrous basis) | 98.0%~102.0% | 99.94% | |
| 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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