| TESTING ITEMS | SPECIFICATIONS | RESULTS |
| Appearance | White to pale yellow solid | Conforms |
| Solubility | Fleely soluble in water | Conforms |
| Identification | IR: Meets the requiremetns | Conforms |
| HPLC: Meets the requirements | Conforms | |
| Test for sodium: Meets the requirements | Conforms | |
| PH | 8.5~9.5 | 8.92 |
| Water | 21.7%~25.7% | 22.86% |
| Heavy metals | ≤20ppm | <20ppm |
| Organic impurities | Phenytoin related compound A ≤0.1% | ND |
| Phenytoin ≤0.1% | 0.02% | |
| Phenytoin related compound B≤0.1% | ND | |
| Any other impurities ≤0.1% | 0.05% | |
| Total impurities ≤0.5% | 0.13% | |
| Assay(HPLC) | 98.0%~102.0% | 99.30% |
| Conclusion: The Product Conforms to Enterprise Standard. |
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