Amiodarone related Compound B/ N-Desethyl Amiodarone Hydrochloride
Descripción
Amiodarone EP Impurity B (CAS 96027-74-6) | también conocida como Amiodarona related Compound B o N-desetilamiodarona clorhidrato | es una impureza relacionada crítica en el control de calidad de la amiodarona. Su caracterización y cuantificación por HPLC con detección UV y espectrometría de masas son esenciales para cumplir especificaciones farmacopéyicas. Presenta propiedades fisicoquímicas y un perfil de degradación que requieren métodos validados para determinación de límite | identificación y cuantificación. La monitorización de esta impureza permite evaluar rutas de síntesis | optimizar condiciones de proceso y almacenamiento | y asegurar la seguridad del ingrediente activo mediante seguimiento rutinario del perfil de impurezas.
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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