Rivaroxaban Nitroso impurity 5 es una impureza de proceso relacionada con las nitrosaminas asociada al anticoagulante xanténico carboxamídico rivaroxabán, que puede formarse en condiciones nitrosantes durante la síntesis o por degradación de intermedios amínicos susceptibles. Los compuestos de esta clase se evalúan conforme a ICH M7 por su posible preocupación mutagénica y genotóxica. La fórmula C13H16ClN3O4 y el peso molecular 313.741000 g/mol describen una especie clorada, rica en nitrógeno y oxígeno, cuya confirmación estructural suele requerir LC-MS/MS, espectrometría de masas de alta resolución y, cuando procede, apoyo de RMN. La cuantificación a nivel traza exige separación cromatográfica con detección selectiva por masa.
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