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Items of Analysis | Standard of Analysis | Test Results |
Appearance | White to off-white powder | Conform |
Purity (HPLC) | ≥98.0% | 99.66% |
TLC | ≥98% | >98% |
Optical Purity | ≤0.5% L-enantiomer | 0.0284% |
Optical Rotation | +15o±3o (C=1 in DMF) | +16.7o |
Element analysis(C、H、N) | ≤5% | <5% |
Clarity of solution | 0.3 gram in 2ml DMF clear solution | Conform |
Water | ≤2.0% | 0.22% |
Loss on drying | ≤2.0% | 0.34% |
Conclusion | Conforms to Factory Standard |
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