Citalopram Related Compound A; Escitalopram EP Impurity A (Hydrochloride salt)
Outros sinônimos
Citalopram Amide
Descrição
Impureza Citalopram EP Impurity A sal de cloridrato é um composto relacionado encontrado no perfil de pureza de lotes de cloridrato de citalopram e escitalopram | identificado como Citalopram Related Compound A ou Citalopram Amide. Esta impureza é monitorada por controle analítico devido ao seu potencial impacto na qualidade e conformidade regulatória do ingrediente farmacêutico ativo. Caracteriza-se por propriedades físico-químicas distintas que exigem avaliação por métodos analíticos validados como HPLC e LC-MS para quantificação e investigação de origem | seja degradativa ou sintética. A definição de limites de especificação e estratégias de controle minimizam riscos ao produto final.
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