Rivaroxaban EP Impurity I (CAS 1151893-81-0) es una impureza relacionada con el principio activo que requiere identificación y control riguroso en el desarrollo y liberación de producto. Su presencia suele originarse durante pasos sintéticos o por degradación y debe caracterizarse mediante técnicas analíticas robustas como HPLC con detección UV | LC-MS y RMN para confirmar estructura y niveles. La evaluación incluye perfil de impurezas | límites aceptables conforme a farmacopeas y validación de métodos analíticos. Su control se logra optimizando condiciones de proceso y purificación | y monitorizando la estabilidad para minimizar riesgos a la calidad y seguridad del medicamento.
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