描述
| Items | Specification |
| Appearance | White to almost white crystalline powder |
| Solubility | Slightly Soluble in Ethanol and in Ether, practically Insoluble in Water |
| Specific optical trorotationrotation | +52°— +60° |
| Loss on drying | ≤1.0% |
| Residual solvent | Dimethylformamide≤880ppm |
| Acetone ≤5000ppm | |
| Methanol≤3000ppm | |
| Dichloromethane≤600ppm | |
| Residual on ignition | ≤0.2% |
| Related substances | Any single impurity ≤1.0% |
| Total impurity≤2.0% | |
| Assay | 97.0%—103.0% |
| Partical size | 99% <10micron |
| Conclusion | The product confirms to USP38 |
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