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Items of Analysis | Standard of Analysis | Test Results |
Appearance | White to off-white powder | White powder |
Purity (HPLC) | ≥95% | 98.6% |
Optical Purity | ≤0.5% D-enantiome | ND |
Clarity of solution | 0.3 gram in 2ml DMF clear solution | Conform |
Melting Point | 120.0-125.0℃ | 120.6-122.5℃ |
Loss on drying | ≤1.0% (60oC,2h) | 0.2% |
Water Content (K. F.) | ≤1.0% | 0.6% |
Specific Rotation | -9.0±1.0°(c=2,DMF) | -8.4° |
Conclusion | Conforms to Factory Standard |
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