Test Items | Specification | Test Results |
Appearance | Yellow powder. | Yellow powder |
Solubility | Slightly soluble in methanol, insoluble in water. | This product is slightly soluble in methanol, insoluble in water. |
Identification | HPLC | The infrared absorption spectrum of this product should be consistent with that of the reference product. | The infrared absorption spectrum of this product should be consistent with that of the reference product. |
IR | The infrared absorption spectrum of this product should be consistent with that of the reference product. | The infrared absorption spectrum of this product should be consistent with that of the reference product. |
Related substance by HPLC | EB04-IMP1 | ≤ 0.15% | 0.03% |
EB04-IMP5 | ≤0.15% | 0.06% |
EB04-IMP7 | ≤0.3% | 0.06% |
Maximum individual impurity | ≤0.10% | 0.06% |
Total impurities | ≤1.0% | 0.30% |
Residue on ignition | ≤0.2% | 0.11% |
Loss on drying | ≤1.0% | 0.32% |
Content (dry matter calculation) | 97.0%-102.0% | 99.9% |
Conclusion | The product conforms to the requirements of Enterprise standard. |
