Powder: | Yes |
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Certification: | GMP |
Suitable for: | Adult |
State: | Solid |
Purity: | >99% |
Transport Package: | Aluminum Foil Bag and Cardboard Bucket |
Customization: |
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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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