Amiodarone Related Compound G / 1-Methoxy Amiodarone
Descripción
La impureza EP G de amiodarona, también denominada Amiodarona Related Compound G o 1-Methoxy Amiodarone, es una impureza aromática de tipo éter, estructuralmente definida, del antiarrítmico benzofuránico amiodarona. Con CAS 1087223-70-8, fórmula molecular C26H31I2NO4 y peso molecular de 675,34 g/mol, corresponde a una O-metilación del oxígeno fenólico respecto del fármaco original. Este análogo suele originarse como subproducto de síntesis o impurity de proceso, más que por degradación oxidativa. Su caracterización y cuantificación requieren habitualmente LC-MS/MS y LC-MS de alta resolución, apoyadas por RMN y LC-UV, debido a su ionización intensa por el contenido de yodo y a su similitud cromatográfica con análogos relacionados.
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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