No abstract

Ezetimibe is an azetidinone derivative and a substituted β-lactam, it is a hypolipidemic agent, and a drug substance that lowers the cholesterol levels in our body. The present work describes the origin, synthesis, and characterization of three impurities of ezetimibe, which are also positional isomers and/or related substances of ezetimibe. viz: o-Fluoro benzene isomer, m-Fluoro aniline analog, and des-fluoro aniline analogs of ezetimibe.

Apixaban is an anticoagulant used to treat venous thromboembolic disorders. The present work describes the origin and synthesis of related substances of Apixaban PG ester‐1 and PG ester‐2. These impurities arise in the process of Apixaban drug substance, later these impurities are transformed into the final Apixaban drug substance. These novel synthesized impurities were characterized by 1H NMR, 13C NMR, HPLC, and HRMS analysis.