| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Non-Customized |
|
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| Batch No. | HF161022 | Quantity | 5.5kgs |
| Mfg. Date | Oct. 22, 2016 | Package | As required |
| Rep. Date | Oct. 25, 2016 | Exp. Date | Oct. 21, 2018 |
| Items | Standards | Results | |
| Appearance | Pale yellow to off-white solid powder | Complies | |
| Identification | By IR | Complies | |
| By HPLC | Complies | ||
| Solubility | Very slightly soluble in water, Methanol and Isopropyl alcohol. | Complies | |
| Polymorphism | Polymorph 1 | Complies | |
| Melting Point | 256.0ºC~260ºC | 257.2ºC~259.3ºC | |
| Loss on Drying | ≤0.50% | 0.30% | |
| Heavy Metal | ≤20ppm | Complies | |
| Residue on Ignition | ≤0.10% | 0.08% | |
| Residual Solvent | Methanol: ≤3000ppm | ND | |
| Ethanol: ≤5000ppm | ND | ||
| Acetone: ≤5000ppm | 490ppm | ||
| Ethyl acetate: ≤5000ppm | 120ppm | ||
| Tetrahydrofuran: ≤720ppm | ND | ||
| Dioxane: ≤380ppm | ND | ||
| Related Substances | Maximum single impurity: ≤0.10% | 0.08% | |
| Total impurities: ≤1.00% | 0.34% | ||
| Assay | 98.0%~102.0% | 99.88% | |
| Particle Size | D90:≤ 50µm | 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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