Di-Desiodo Amiodarone HCl / Amiodarone Related Compound A (HCl salt)
Descripción
Amiodarone EP Impurity A (HCl salt) | CAS 95820-13-6 | es la forma clorhidrato de la impureza di-desiodo de la amiodarona identificada como Amiodarone Related Compound A. Esta impureza orgánica requiere monitorización en control de calidad farmacéutico por su impacto en el perfil de pureza y cumplimiento de especificaciones EP. Sus características analíticas incluyen mayor polaridad por la sal clorhidrato | posible desplazamiento cromatográfico en HPLC de alta resolución y firma específica en espectrometría de masas. Se recomienda cuantificación mediante HPLC con detección UV o LC-MS para límites de trazas | establecimiento de límites de aceptación y evaluación en estudios de estabilidad.
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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