Key result
Novel synthesized Apixaban impurities PG ester-1 and PG ester-2 undergo successful analytical characterization.
This study describes the synthesis and characterization of two novel impurities arising during the production of the anticoagulant apixaban.
May inform apixaban quality control; leaves open clinical safety implications.
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 1 H NMR, 13 C NMR, HPLC, and HRMS analysis.
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Satheesh et al. (2022) studied venous thromboembolic disorders. Apixaban was evaluated. Novel synthesized impurities of Apixaban, PG ester-1 and PG ester-2, were successfully characterized using 1H NMR, 13C NMR, HPLC, and HRMS analysis.
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