| Varieties: | Other |
|---|---|
| Component: | Chemical Synthetic Drugs |
| Type: | Other |
| Pharmacodynamic Influential Factors: | Other |
| Storage Method: | Prevent Exceeding Quality Guarantee Period |
| Veterinary Reg. No.: | Other |
| Customization: |
|---|
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| Name of product | Clavulanate Potassium-Silicon Dioxide(1:1) | |
| Tests | Specifications | Results |
| Appearance | A white or almost white powder, hygroscopic | A white powder, hygroscopic |
| Identification | (1) The principal peak in the chromatogram obtained with the test solution is similar in retention time to the principal peak in the chromatogram obtained with reference solution (a). | Conforms |
| (2)lt gives reaction (b) of potassium. | Conforms | |
| (3) It gives the reaction of silicates | Conforms | |
| PH | 4.8 ~8.0 | 5.1 |
| Absorbance | ≤0.40(278nm) | 0.064 |
| Related substances | Impurity E≤1.0% | 0.09% |
| Impurity G≤1.0% | <Reporting threshold limit0.05% | |
| Any other impurity ≤ 0.2% | <Reporting threshold limit0.05% | |
| Total impurities≤ 2.0% | 0.09% | |
| water | ≤2.5% | 0.53% |
| Residual Solvents | Acetone≤5000ppm | 48ppm |
| 1-butanol≤5000ppm | 909ppm | |
| Assay | It contains Potassium Clavulanate(C8H8KNO5)48.0%~53.5%,calculated on the anhydrous basis. | 49.9% |
| Conclusion | The results conform with EP and Enterprise standard. | |
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