Item | Specification | Results |
Description |
Practically white,crystalline powder.
Very slightly soluble in water and in insoluble in other common organic |
conform |
Identification | ||
A.Infrared absorption | To match with the reference IR spectrum | conform |
B.Specific optical rotation | meet the requirements | conform |
C.HPLC | The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay | conform |
Assay | 97.5%~102.0% | 99.0% |
Related compounds | ||
1.Individual impurity | NMT1.0% | 0.06% |
2.Total impurities | NMT2.0% | 0.06% |
Residual Solvents(Toluene) | ≤890ppm | <20ppm |
Optical Rotation | +89° - +93° | +90.6° |