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Items of Analysis | Standard of Analysis | Test Results |
Appearance | White to off-white powder | White powder |
IR | IR spectrum match with reference standard | Conforms |
Water (KF) | ≤0.5% | 0.3% |
Residue on Ignition | ≤0.5% | 0.4% |
Optical rotation | -34.8°~-30.5° | -32.6° |
Loss on drying | ≤1.0% | 0.4% |
Heavy metals | ≤20ppm | Conforms |
Melting Point | 94.0-97.5℃ | 94.4-94.7℃ |
Assay(HPLC) | 98.0%~102.0% | 99.0% |
Conclusion | Conforms to Factory Standard |
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