| Testing Items | Specifications | Results |
| Characters | White or almost white powder | Complies |
| Identification | IR and UV similar to standard | Complies |
| Appearance of solution | The solution is clear and not more intensely colored than reference solutions Y7 | Complies |
| Solubility | Insoluble in ether, very slightly soluble in water and in isopropyl alcohol, slightly soluble in alcohol in chloroform and in propylene glycol, sparingly soluble in methanol, soluble in dimethyl formamide, freely soluble in dimethylsul foxide. | Complies |
| Optical rotation | -0.1°~+0.1° | 0° |
| Related substances | Each impurity ≤0.25% | 0.21% |
| Total impurity ≤0.50% | 0.32% | |
| Melting point | 178℃~184℃ | 182.1℃~183.4℃ |
| Loss on drying | ≤0.50% | 0.18% |
| Residue on ignition | ≤0.10% | 0.06% |
| Residue solvents | Toluene ≤890ppm | 120ppm |
| Ethanol ≤600ppm | 100ppm | |
| Assay | 98.5%~101.0% | 99.4% |
| Conclusion: The Product Conforms to USP/BP. |
||
