Identification and Synthesis of Impurities During a Novel Process Development of Rivaroxaban

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Identification and Synthesis of Impurities During a Novel Process Development of Rivaroxaban

Yu, Jun; Qiu, Peng‐Cheng; Ke, Bin; Chen, Hui; Zhao, Chuan‐Meng; Zhang, Fu‐Li

Journal of heterocyclic chemistry, December 2018, 2018-12-00, 20181201, Volume: 55, Issue: 12

Journal Article

During the development of rivaroxaban, seven process‐related impurities have been identified and synthesized. These structures are confirmed by nuclear magnetic resonance spectroscopy and high‐resolution mass spectrometry. The impurities (S)‐2‐(2‐((4‐(5‐(aminomethyl)‐2‐oxooxazolidin‐3‐yl)phenyl)amino)ethoxy)acetohydrazide (A) and (S)‐4‐(4‐(((2‐oxooxazolidin‐5‐yl)methyl)amino)phenyl)morpholin‐3‐one (F) are confirmed and distinguished from their isomers by single‐crystal diffraction. This work proves to be valuable in regard to complying with regulatory norms and assessing the quality of rivaroxaban.

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