| Testing items | Specifications | Results |
| Description | Grayish-yellow or light yellow hygroscopic powder | Conforms |
| Solubility | Practically insoluble in water, soluble in dimethyl sulfoxide, practically insoluble in alcohol, it dissolves in dilute solutions of alkali hydroxides | Conforms |
| Identification |
|
Conforms |
|
Conforms | |
| Water | ≤6.0% | 3.38% |
| Pyridine | ≤200ppm | 110ppm |
| Heavy metals | ≤20ppm | Conforms |
| Sulfate ash | ≤0.2% | 0.14% |
| Iodine | ≤0.1% | Conforms |
| Related substances | Impurity A ≤0.5% | 0.07% |
| Impurity B ≤4.0% | 0.39% | |
| Impurity C ≤3.0% | 2.36% | |
| Impurity D ≤0.6% | 0.00% | |
| Impurity E ≤3.0% | 1.90% | |
| Any other impurity ≤0.40% | 0.18% | |
| Total impurities ≤8.5% | 5.34% | |
| Microbiological test | Total Plate Count ≤1000cfu/g | 40cfu/g |
| Yeast and Molds ≤100cfu/g | 10cfu/g | |
| E.Coliform: Negative in 1g | Negative in 1g | |
| Assay | 90.0%~102.0% | 94.4% |
| Conclusion: The Product Conforms to USP/EP. |
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