Study on the Critical Quality Attributes of Tebipenem Pivoxil Fine Granules

OBJECTIVE To research the critical quality attributes of reference listed drug, in order to develop the generic drug of tebipenem pivoxil fine granules. METHODS The critical quality attributes of the active pharmaceutical ingredient including solubility, stress testing and stability in different solvent were researched and evaluated. The critical quality attributes of reference listed drug of tebipenem pivoxil fine granules including dissolution, particle size distribution, related substance and assay were researched and evaluated as well. RESULTS The active pharmaceutical ingredient was very slightly soluble in water, and the solubility was pH-dependent. The stronger the acidity, the greater the solubility, but it quickly degraded in pH 1.0 and pH 2.0 solutions. The reference listed drug was dissolving rapidly in the acid medium, and most of the particle distributed in the range of 30 mesh to 120 mesh. The content was 100.8%, and the content of impurity tebipenem was 0.05%. CONCLUSION The critical quality attributes of active pharmaceutical ingredient and reference listed drug will help the development of generic drug of tebipenem pivoxil fine granules.