Key result
Seven process-related impurities were identified and synthesized during the development of rivaroxaban, with structures confirmed by NMR, mass spectrometry, and single-crystal diffraction.
The identification and synthesis of process-related impurities of rivaroxaban provides valuable reference material for quality assessment and regulatory compliance.
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May aid rivaroxaban quality control and regulatory compliance; leaves open clinical validation of impurity relevance.
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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Yu et al. (2018) studied this question. Rivaroxaban process development was evaluated on Identification and synthesis of process-related impurities. Seven process-related impurities were identified and synthesized during the development of rivaroxaban, with structures confirmed by NMR, mass spectrometry, and single-crystal diffraction.
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