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Items of Analysis | Standard of Analysis | Test Results |
Appearance | White to off-white powder | Conform |
Purity (HPLC) | ≥98.0% | 99.48% |
Optical Purity | ≤0.5% D-enantiomer | ND |
TLC | ≥98.0% | >98.0% |
Melting point | 165-178℃ | 169.9-175.0℃ |
Specific Rotation[a]20D | -32o±2o (C=1 in DMF) | -32.8o |
Clarity of solution | 0.3 gram in 2ml DMF clear solution | Conform |
Water | ≤1.0% | 0.08% |
Loss on drying | ≤1.0% | 0.34% |
Conclusion | Conforms to Factory Standard |
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