La impureza acetilo de empagliflozina, CAS 1079083-63-8, es una sustancia relacionada de origen de proceso y degradación del inhibidor SGLT2 empagliflozina, caracterizada por la modificación acetilada de la función alcohol bencílico dentro del marco C27H29ClO10, con peso molecular de 548,97 g/mol. Esta impureza puede generarse por transferencia de acilo durante la síntesis o por reacciones secundarias con reactivos acetilantes, y debe diferenciarse de análogos posicionales y estereoquímicos mediante métodos ortogonales. La elucidación estructural y la cuantificación a nivel traza suelen requerir LC-MS/MS, MS de alta resolución y LC-UV con resolución cromatográfica específica de impureza. Su presencia es pertinente para el perfil de impurezas y la evaluación de estabilidad bajo criterios ICH.
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