Desiodo Amiodarone HCl / Amiodarone Related Compound C
Descripción
La impureza EP C de amiodarona, también designada Amiodarone Related Compound C o desyodo amiodarona (base libre), es el análogo desyodado del esqueleto benzofuránico antiarrítmico. El CAS 85642-08-6 corresponde a C25H30INO3 con un peso molecular de 519.13, conservando los sustituyentes ariloxietanolamina y dietilaminoetoxi, pero sin el átomo de yodo característico de la amiodarona. Su origen se asocia principalmente con deshalogenación sintética u oxidación biotransformativa, no con química de nitrosaminas. Para su caracterización y cuantificación a nivel traza suelen requerirse LC-MS/MS, LC-MS de alta resolución y, cuando la volatilidad lo permite, GC-MS, debido a la dificultad de separar análogos posicionales y halogenados muy próximos.
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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