La Impureza EP F de amiodarona, también denominada Compuesto Relacionado F de amiodarona, es un derivado fenoxi de benzofurano yodado identificado por el CAS 147030-50-0. Con fórmula molecular C19H17IO3 y peso molecular 420.24, corresponde a una impureza relacionada de proceso o de degradación dentro del perfil sintético y de estabilidad de la amiodarona. Sus funciones de éter aromático y benzofurano favorecen la retención en LC de fase reversa, mientras que la evaluación a nivel traza suele requerir LC-MS/MS y, para confirmación estructural concluyente, MS de alta resolución o RMN. En el contexto regulatorio se considera una sustancia relacionada especificada bajo los esquemas farmacopéicos de control de impurezas.
Referencias
Karmarkar, S., et al. “Quality by Design (QbD) Based Development and Validation of an HPLC Method for Amiodarone Hydrochloride and Its Impurities in the Drug Substance.â€Â Journal of Pharmaceutical and Biomedical Analysis, vol. 100, Nov. 2014, pp. 167–74, https://doi.org/10.1016/j.jpba.2014.07.002.
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