La impureza Rivaroxaban 67, CAS 1082495-22-4, es una impureza heteroaromática de bajo peso molecular con fórmula molecular C10H12N2O2 y peso molecular de 192.21 g/mol. Su composición es compatible con una especie nitrogenada derivada de piridina, originada a partir de intermedios de síntesis, subproductos de proceso o degradación oxidativa de precursores relacionados con rivaroxabán. Debido a sus características estructurales y a la posible coelución con especies afines, la determinación a nivel traza suele requerir LC-MS/MS ortogonal y, cuando la volatilidad lo permite, confirmación por GC-MS. En el contexto regulatorio, estas impurezas se evalúan bajo los principios de control de impurezas e ICH M7 cuando existen alertas estructurales de riesgo mutagénico.
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