| Testing items | Specifications | Results |
| Description | White to off-white powder | Conforms |
| Solubility | Freely soluble in methylene chloride, soluble in acetone and in methanol, sparingly soluble in ethyl acetate and in alcohol, practically in soluble in hexane and in water | Conforms |
| Identification |
|
Conforms |
|
Conforms | |
| Melting range | 198℃~203℃ | 199.4℃ |
| Water determination | ≤0.20% | 0.04% |
| Optical rotation | -187°~-193° | -189° |
| Inorganic impurities | Residue on ignition ≤0.1% | 0.05% |
| Heavy metals ≤20ppm | <20ppm | |
| Organic impurities | 1,2-dimethoxy-ethane≤0.20% Diisopropyl ether≤0.10% |
Conforms |
| Impurity A ≤0.10% | Conforms | |
| Impurity B ≤0.10% | Conforms | |
| Impurity C ≤0.10% | Conforms | |
| Impurity D ≤0.10% | Conforms | |
| Impurity E ≤0.10% | Conforms | |
| Unspecified impurities ≤0.10% | 0.04% | |
| Total impurities ≤0.40% | 0.10% | |
| Assay | 98.0%~102.0% | 99.89% |
| Conclusion: The Product Conforms to USP/EP. |
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