4-(3-Clorofenil)-1-nitrosopiperazina (CAS 2219339-13-4) | también conocida como 1-(3-clorofenil)-4-nitrosopiperazina | es una impureza nitrosada que aparece por nitrosación de intermediarios piperazínicos durante síntesis. Su grupo nitroso confiere un perfil toxicológico que exige control estricto en el perfil de impurezas. Técnicas analíticas validadas como HPLC con detección UV | LC-MS/HRMS y NMR son recomendadas para identificación | cuantificación y estudio de estabilidad. El control de proceso | optimización de condiciones de reacción y pasos de purificación minimizan su formación | y la definición de límites según guías regulatorias e ICH M7 con LOD/LOQ adecuados es esencial para asegurar calidad y seguridad.
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