Citalopram Impurity 1 (sal de sódio) é uma impureza identificada durante a síntese e purificação do citalopram que requer monitoramento rigoroso no controle de qualidade farmacêutico. Apresenta características físico-químicas como maior solubilidade em meios aquosos na forma de sal de sódio e perfil cromatográfico distinto | detectável por HPLC e confirmado por LC-MS e RMN. Avaliação de estabilidade | limites de aceitação e métodos de quantificação validados são essenciais para garantir conformidade regulatória. Fornece referência para desenvolvimento de métodos analíticos | investigação de origem na rota sintética e definição de medidas de mitigação para minimizar impacto na pureza do produto final.
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