Complaint
Potassium clavulanate alone is not effective. Often used in combination with penicillin drugs to overcome microbial resistance caused by β-lactamase, and improve the efficacy.
Clavulanate potassium combined with amoxicillin can inhibit Staphylococcus aureus, Haemophilus influenzae, catarrhal bacteria. Escherichia coli, Klebsiella, Proteus mirabilis, Proteus vulgaris, Neisseria gonorrhoeae, Legionella, Bacteroides fragilis and other microorganisms produce β-lactamase damage to amoxicillin, so the pathogen of the enzyme or not Enzyme-producing strains effective.
Clavulanate potassium also does not produce β-lactamase-producing Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus green, Clostridium, Peptococcus, Peptostreptococcus also have antibacterial effects.
| 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. | |
