Items | Standard | Results | |
Description | White or almost white crystalline powder | Almost white crystalline powder | |
Identification | HPLC complies with the standard | complies | |
Specific rotation | +19°~ +23° | +22.6° | |
Loss on drying | max. 0.5% | 0.05% | |
Residue on ignition | max. 0.2% | 0.04% | |
Heavy metal | max. 20 ppm | complies | |
Related substances (HPLC) | -Single impurity | max.0.3% | 0.11% |
-total impurities | max.1.0% | 0.23% | |
Assay (based on drying) | Not less than 98.0% | 100.8% | |
Conclusion: The product complies with the Enterprise Standard. Storage condition: room temperature, in a closed container. |