Quality control and consistency evaluation of ceftriaxone sodium for injection

Abstract

Ceftriaxone sodium for injection is an antibiotic used clinically. Here, we developed a strategy for evaluating the consistency of ceftriaxone sodium for injection. Comparison of the quality of the generic and original raw materials, and analysis of the production process revealed that the quality of the ceftriaxone sodium raw material is the most important factor affecting the quality of preparation, while the ceftriaxone sodium crystallization process is the key factor affecting the quality of raw materials. The solution clarity of the formulation, another key aspect, was addressed by controlling the leachable components found in the rubber closures used in the packaging. The time to achieve therapeutic efficacy of the preparation could be preliminarily evaluated by evaluating the rate of salt formation and the protein binding rate. Finally, the results of the tests (including water, pH, impurity profile and solution clarity) and assay were compared with the original preparation. On this basis, the critical quality attributes (CQAs) that reflect the quality of the product could be determined and a strategy for evaluating ceftriaxone sodium for injection was developed.