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Items of Analysis | Standard of Analysis | Test Results |
Appearance | Pale yellow to almost white solid | Conform |
Solubility | Soluble in CHCl3 | Conform |
Specific optical rotation | +52.0~57.0°(c 1.23, CHCl3) | +53.9° |
Loss on Drying | Not more than 0.7% | 0.25% |
Assay by HPLC | Not less than 98 % | Conform |
LK-7 | Not more than 0.2% | Conform |
Other largest single impurity | Not more than 0.1% | Conform |
Conclusion | Conforms to Factory Standard |
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