Synthesis and control of process-related impurities in the β-lactamase inhibitor drug substance zidebactam

Abstract

Zidebactam is a novel extended spectrum β-lactamase inhibitor (ESBLI). It’s combination with cefepime (WCK 5222) is in phase III clinical studies. Five process impurities were found in zidebactam (1) drug substance using process development through reverse phase high performance liquid chromatography (HPLC) method. To give access to the reference standards for the impurity profile of the drug substance as well as the final product, these process impurities of compound 1, have been synthesized and characterized.

Graphical Abstract

Keywords:

• β-lactamase inhibitor
• impurities
• stereoisomer
• zidebactam

Acknowledgments

The authors are thankful to the management of Wockhardt Ltd. for supporting this work. Authors also acknowledge all the team members of chemical and analytical research development of Wockhardt Research Centre, Aurangabad for their support in conducting this research work.