| Testing items | Specifications | Results |
| Description | White or yellowish, crystalline powder | Conforms |
| Solubility | Sparingly soluble in water, soluble in methanol, practically insoluble in methylene chloride | Conforms |
| Identification |
|
Conforms |
|
Conforms | |
|
Conforms | |
|
Conforms | |
| PH | 4.5~6.0 | 5.2 |
| Loss on drying | ≤0.50% | 0.1% |
| Residue on ignition | ≤0.10% | 0.05% |
| Heavy metals | ≤20ppm | <20ppm |
| Related substances | 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% | 0.06% | |
| Total impurities ≤0.30% | 0.10% | |
| Assay | 99.0%~101.0% | 99.80% |
| Conclusion: The Product Conforms to USP/EP. |
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