Amiodarone Related Compound A / Di-Desiodo Amiodarone
Descripción
La Impureza A de Amiodarona EP, también denominada Compuesto Relacionado A de Amiodarona o di-desiodo amiodarona en base libre, es el análogo desyodado de la amiodarona y constituye una impureza de proceso estructuralmente definida, no una especie mutagénica reactiva. Se identifica con CAS 23551-25-9, fórmula molecular C25H31NO3 y peso molecular 393.52. Su formación suele asociarse con control incompleto de la yodación, deshalogenación reductora o arrastre de subproductos de síntesis. Dado su esqueleto benzofuránico altamente lipófilo, la determinación a nivel traza suele requerir LC-MS/MS o LC-HRMS, con confirmación por UV y comparación cromatográfica. Su presencia se interpreta dentro de perfiles de impurezas y estudios indicativos de estabilidad bajo criterios farmacopeicos e ICH.
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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