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Items of Analysis | Standard of Analysis | Test Results |
Appearance | White powder | Conform |
Purity (HPLC) | ≥98.0% | 99.95% |
Optical Purity | ≤0.5% D-enantiomer | 0.0715% |
TLC | ≥98% | >98% |
Melting point | 160-190℃ | 174.1-181.3℃ |
Specific Rotation[a]20D | +30o±4o (C=1 in DMF) | +28.4o |
Clarity of solution | 0.3 gram in 2ml DMF clear solution | Conform |
Water | ≤2.0% | 0.85% |
Loss on drying | ≤2.0% | 1.30% |
Element analysis(C、H、N) | ≤5% | <5% |
Conclusion | Conforms to Factory Standard |
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