Amiodarone EP Impurity C (HCl salt) | CAS 1397201-93-2 | es una impureza crítica en el control de calidad del principio activo amiodarona y debe ser monitoreada por su impacto en el perfil de pureza. Su forma salina de clorhidrato modifica propiedades fisicoquímicas como solubilidad e ionización | influyendo en retención cromatográfica y detección por LC-MS. La identificación y cuantificación se realiza típicamente mediante HPLC con detección adecuada y confirmación por espectrometría de masas y RMN. Las especificaciones y métodos validados para esta impureza son esenciales para garantizar estabilidad | consistencia de lote y cumplimiento normativo.
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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