Amiodarone EP Impurity G (HCl Salt) | também referida como Amiodarone Related Compound G | é uma impureza sintética relevante em matérias-primas e lotes de amiodarona cuja identificação e quantificação são essenciais para controle de qualidade. Apresenta propriedades fisicoquímicas distintas | maior solubilidade em meio aquoso ácido devido à forma salina | e pode se formar por reações de degradação ou por impurezas na síntese. Métodos analíticos como HPLC com detecção UV e LC-MS são recomendados para rastreio e perfilamento | com limites de detecção e validação alinhados às monografias e boas práticas para garantir segurança e conformidade.
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