| TESTING ITEMS | SPECIFICATIONS | RESULTS |
| Characteristics | White to off-white crystalline powder | Conforms |
| Identification | Meet the requirements | Conforms |
| Related substances | Any individual impurity ≤1.0% | 0.03% |
| Any other single impurity ≤0.1% | 0.05% | |
| Total impurities ≤3.5% | 1.7% | |
| Loss on drying | ≤2.0% | 0.08% |
| Residue on ignition | ≤0.1% | 0.06% |
| Chloride | ≤0.02% | <0.02% |
| Sulfate | ≤0.04% | <0.04% |
| Heavy metals | ≤20ppm | <20ppm |
| PH | 8.0~10.0 | 8.5 |
| Assay | 98.0%~102.0% | 99.63% |
| Conclusion: The Product Conforms to USP/EP. |
||
