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Item | Requirements | Test Results |
Appearance | while to off-while powder | White powder |
Identification | HPLC retention time | Conforms |
Melting Point | 42 ºC -45°C | 42°C-44°C |
Specific optical rotation | -31.0°~-41.0° | -36.0° |
Purity by HPLC | no less than 98.0% | 98.5% |
Total impurity | no more than 2.0% | 1.6% |
Max Individual impurity | no more than 0.5% | 0.3% |
Water content%(K&F) | no more than 0.5% | 0.1% |
Residual solvents | EtOH no more than 0.5% | N.D |
EtAC no more than 0.5% | N.D | |
nHeptane no more than 0.5% | less than 0.1% | |
Residue on ignition | less than 0.2% | 0.10% |
Assay (HPLC) | no less than 98.0% | 98.60% |
Conclusion | Meets the Requirements |