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Items of Analysis | Standard of Analysis | Test Results |
Appearance | White to off-white powder | Conform |
Purity (HPLC) | ≥98.0% | 99.82% |
Optical Purity | ≤0.5% L-enantiomer | 0.0542% |
Melting point | 152-168℃ | 158.6-162.9℃ |
Specific Rotation[a]20D | -26o±2o (C=1 in MeOH) | -26.5o |
Clarity of solution | 0.3 gram in 2ml DMF clear solution | Conform |
Water | ≤2.0% | 0.13% |
Loss on drying | ≤2.0% | 0.14% |
Conclusion | Conforms to Factory Standard |
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