N-Nitroso Eltrombopag Methyl Ester Impurity es una impureza de proceso relacionada con una nitrosamina, derivada del armazón de eltrombopag éster metílico y compatible con una nitrosación inadvertida durante la síntesis, el tratamiento o el almacenamiento en presencia de nitrito. Con fórmula molecular C26H23N5O5 y peso molecular de 485,50 g/mol, se trata de un análogo N-nitroso estructuralmente definido que exige evaluación regulatoria por su posible carácter genotóxico conforme a ICH M7. Su caracterización suele requerir LC-MS/MS para la cuantificación traza, junto con MS de alta resolución y métodos ortogonales LC-UV; la confirmación puede apoyarse en RMN y, si la volatilidad lo permite, GC-MS.
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