N-Nitroso Eltrombopag Impurity 1 es un degradante relacionado con nitrosaminas de eltrombopag, definido estructuralmente por la N-nitrosación del motivo amino heteroaromático del compuesto original. Con fórmula molecular C12H13N3O2 y peso molecular de 231.25 g/mol, constituye una impureza potencialmente genotóxica, derivada del proceso o del almacenamiento, que puede formarse bajo condiciones nitrosantes, especialmente en presencia de precursores amínicos secundarios y especies reactivas de nitrito. Estas entidades se evalúan dentro del marco regulatorio para impurezas de nitrosaminas y conforme a los principios de ICH M7. Su determinación traza suele requerir LC-MS/MS con confirmación por MS de alta resolución y, cuando la volatilidad lo permite, GC-MS para caracterización ortogonal.
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