N-Nitroso Clonidine Impurity (CAS 148950-49-6) | conocido también como 1-nitroso clonidina | N-(2 | 6-diclorofenil)-1-nitroso-4 | 5-dihidro-1H-imidazol-2-amina o Clonidine Impurity 5 | es una impureza nitrosada que exige control analítico y regulatorio riguroso. Se forma por nitrosación de precursores clorados en presencia de agentes nitrosantes y condiciones ácidas | y se clasifica como nitrosamina potencialmente genotóxica | por lo que su cuantificación a niveles de ppb mediante LC-MS/MS | GC-MS o HRMS es crítica. Su caracterización por RMN y espectrometría de masas completa la identificación. Las estrategias de control incluyen optimización de síntesis | purificación dirigida | uso de inhibidores y límites de retención y estabilidad documentados en especificaciones y registros de lote.
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