N-Nitroso Upadacitinib (Posibilidad 1) es una impureza de proceso relacionada con nitrosaminas de upadacitinib, originada de forma plausible por nitrosación del nitrógeno piperidínico o del nitrógeno asociado a la amida bajo condiciones que generan especies nitrosantes durante la síntesis, el almacenamiento o por arrastre de reactivos. Con fórmula molecular C17H18F3N7O2 y peso molecular de 409,4 g/mol, pertenece a la clase de impurezas potencialmente mutagénicas contempladas por los principios de ICH M7, ya que las funciones N-nitroso se asocian habitualmente con preocupación genotóxica. Su confirmación estructural y cuantificación a nivel traza suelen requerir LC-MS/MS, MS de alta resolución y, cuando la volatilidad lo permite, GC-MS.
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