Valsartan Nitroso VAM-II es una impureza N-nitroso asociada a valsartán, perteneciente a la clase de las nitrosaminas y compatible estructuralmente con un derivado N-nitrosado generado bajo condiciones nitrosantes durante la síntesis, el procesamiento o el almacenamiento. Con fórmula molecular C20H21N3O3 y peso molecular de 351.40 g/mol, se ajusta al perfil de un contaminante traza con potencial genotóxico, sujeto a control estricto conforme a ICH M7 y a las evaluaciones regulatorias actuales sobre nitrosaminas. Su detección y cuantificación suelen requerir LC-MS/MS de alta selectividad, a menudo complementada con espectrometría de masas de alta resolución, ya que la detección UV carece de sensibilidad y especificidad suficientes. Se considera dentro del perfil de impurezas de valsartán.
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