Amiodarone Related Compound G / 1-Methoxy Amiodarone
Descrição
A impureza EP G de amiodarona, também denominada Amiodarona Related Compound G ou 1-Methoxy Amiodarone, é uma impureza aromática do tipo éter, estruturalmente definida, do antiarrítmico benzofurânico amiodarona. Com CAS 1087223-70-8, fórmula molecular C26H31I2NO4 e massa molecular de 675,34 g/mol, corresponde à O-metilação do oxigênio fenólico em relação ao fármaco de origem. Esse análogo costuma surgir como subproduto de síntese ou impureza de processo, mais do que por degradação oxidativa. Sua caracterização e quantificação normalmente exigem LC-MS/MS e LC-MS de alta resolução, com apoio de RMN e LC-UV, devido ao comportamento de ionização dos derivados iodados e à proximidade cromatográfica com análogos relacionados.
Referências
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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