Impureza nitrosamina de vareniclina es una impureza crítica identificada durante estudios de degradación y control de calidad. Varenicline Impurity 9 requiere evaluación cuantitativa mediante métodos analíticos validados como LC-MS/MS y GC-MS con límites de detección adecuados y procedimientos de extracción y concentración específicos. El perfil analítico debe incluir criterios de selectividad | linealidad | recuperación y robustez conforme a guías regulatorias ICH Q2(R1) y requisitos compendiales. El control de este nitrosamino es esencial para garantizar la seguridad del producto farmacéutico | establecer límites de aceptación y definir estrategias de mitigación durante desarrollo y fabricación.
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