Powder: | Yes |
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Customized: | Customized |
Certification: | GMP, ISO 9001, USP, BP, SGS |
Suitable for: | Elderly, Children, Adult |
State: | White Powder |
Purity: | >98% |
Samples: |
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Customization: |
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Items | Specifications | Result |
Appearance | Off-white to white powder | Conforms |
Identification | ||
H-NMR | Should conforms to the standard | Conforms |
Chromatography | The retention time of the principal peak in the sample preparation should correspond with the retention time of the principal peak in the related substances composite solution for system suitability | Conforms |
Purity (HPLC) | Purity: ≥99.5% Any single impurity: ≤0.1% |
99.88% 0.082 |
Water content (KF) | ≤0.5% | 0.11% |
Optical specific rotation | -27°~31° | -29.234° |
Loss on drying (LOD) | ≤0.5% | 0.11% |
Heavy metals (Pd) ICP | ≤10ppm | 7.1ppm |
Solvent remains(GC) | Methano l: ≤3000ppm Dichloromethan e: ≤600ppm Isopropy l alcohol: ≤3000ppm Aceton e: ≤5000ppm Dimethy l sulfoxide: ≤5000ppm |
50.60ppm 58.03ppm 68.29ppm 57.14ppm 3407.18ppm |
Enantiomeric purity CNP-HPLC |
Enantiomers: ≤0.1% |
N.D |
Melting point (MP) | 167ºC~171ºC | 168.3ºC·170.6ºC |
Conclusion | Complies with the specifications. |
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