N-Nitroso Losartan EP Impurity F es una impureza nitrosada asociada al principio activo Losartan que requiere vigilancia por su potencial genotóxico. Técnicamente, su presencia se evalúa como parte del control de calidad de lotes y estudios de estabilidad, investigando rutas de formación durante síntesis y almacenamiento. La caracterización y cuantificación se realizan mediante métodos analíticos validados como LC-MS/MS y GC-MS con cromatografía de alta resolución, acompañados de procedimientos de extracción y enriquecimiento. Los límites de aceptación y estrategias de reducción se establecen tras evaluación de riesgo, cumplimiento de guías regulatorias aplicables e implementación de medidas de mitigación en el proceso.
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