Amiodarone Methoxy Impurity (CAS 83790-87-8) es una impureza orgánica relacionada estructuralmente con la amiodarona | generada por O-metilación o como producto de degradación durante síntesis y almacenamiento. Su perfil analítico incluye retención característica en HPLC | ionización en LC-MS y señales diagnósticas en RMN que permiten identificación y cuantificación con límites de detección bajos. Estudios de estabilidad muestran formación bajo condiciones oxidativas y fotolíticas | por lo que el control se basa en optimización de pasos sintéticos | purificación cromatográfica y especificaciones según ICH Q3A. La monitorización robusta de esta impureza garantiza la integridad del perfil de impurezas del lote y cumplimiento regulatorio.
Referencias
Lacrok, Pauline M., et al. “Liquid Chromatographic Determination of Amiodarone Hydrochloride and Related Compounds in Raw Materials and Tablets.â€Â Journal of AOAC INTERNATIONAL, vol. 77, no. 6, Nov. 1994, pp. 1447–53, https://doi.org/10.1093/jaoac/77.6.1447.
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