| Customization: | Available |
|---|---|
| Powder: | Yes |
| Certification: | GMP |
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| Batch No. | HF161208 | Quantity | 12.2kgs |
| Mfg. Date | Dec. 08, 2016 | Package | As required |
| Rep. Date | Dec. 11, 2016 | Exp. Date | Dec. 07, 2018 |
| Items | Standards | Results | |
| Appearance | White crystalline powder | Complies | |
| Identification | By IR | Complies | |
| By HPLC | Complies | ||
| Melting Point | 74ºC~79ºC | 75.0~77.1ºC | |
| Water Content(KF) | 5.0%~7.0% | 4.44% | |
| Residue on Ignition | ≤ 0.10% | 0.06% | |
| Heavy Metals | ≤20ppm | Complies | |
| Sulfate | Complies with the requirement | Complies | |
| Residual Solvents | Isop ropyl Acetate: ≤5000ppm | ND | |
| Acet one: ≤5000ppm | ND | ||
| Iso propanol: ≤5000ppm | ND | ||
| Related Substance | Any single impurity: ≤0.50% | Complies | |
| Total Impurities: ≤1.00% | 0.12% | ||
| Assay (on the anhydrous basis) |
97.5%~101.0% | 99.84% | |
| Reference Standard | USP36 Standard | ||
| Conclusion | The product complied to In-house standard. | ||
| Storage | Preserve in tight,light-resistant containers in a cool place |
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