| Testing Items | Specifications | Results |
| Appearance | White to off-white powder | Conforms |
| Solubility | Freely soluble in water and in methanol, practically insoluble in ether | Conforms |
| Identification(HPLC) | Positive | Conforms |
| Loss on drying | ≤0.50% | 0.04% |
| Residue on ignition | ≤0.10% | 0.05% |
| Related compounds | ≤0.20% | 0.06% |
| First enantiomer of Related compounds B | ≤0.30% | 0.07% |
| Related compounds C | ≤1.00% | 0.05% |
| Any other impurity | ≤0.10% | 0.08% |
| Total impurities | ≤1.50% | 0.26% |
| Acetone | ≤5000ppm | <5000ppm |
| Ethyl acetate | ≤5000ppm | <5000ppm |
| Methylene dichloride | ≤600ppm | <600ppm |
| Assay | 97.0~101.5% | 100.3% |
| Conclusion: The Product Conforms to USP. |
||
