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Items of Analysis | Standard of Analysis | Test Results |
Appearance | White powder | Conform |
Purity (HPLC) | ≥98.0% | 99.31% |
TLC | ≥98.0% | >98.0% |
Optical Purity | ≤0.5% L-enantiomer | ND |
Specific Rotation[a]20D | +4.5o±1.5o (C=1 in DMF) | +5.7o |
Clarity of solution | 0.3 gram in 2ml DMF clear solution | Conform |
Water | ≤2.0% | 0.16% |
Loss on drying | ≤2.0% | 0.12% |
Kaiser Test | <0.05% | <0.05% |
Element analysis(C、H、N) | ≤5.0% | <5.0% |
Conclusion | Conforms to Factory Standard |
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