Di-Desiodo Amiodarone HCl / Amiodarone Related Compound A (HCl salt)
Descrição
Amiodarone EP Impurity A (HCl salt) | CAS 95820-13-6 | também conhecida como Di-Desiodo Amiodarone HCl ou Amiodarone Related Compound A (HCl salt) | é um produto de degradação relevante no perfil de qualidade do amiodarona. Como sal de cloridrato | exibe solubilidade e comportamento cromatográfico distintos que afetam detecção por HPLC-UV e identificação por LC-MS. Sua presença indica vias de desiodação e pode influenciar especificações por limite e avaliação toxicológica; por isso requer padrões de referência apropriados | métodos validados para quantificação e estratégias de controle durante síntese e armazenamento. Monitoramento contínuo é imprescindível para conformidade regulatória.
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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