Impureza 28 do Citalopram (sal cloreto) é um subproduto identificado no perfil de impurezas do citalopram que requer caracterização rigorosa por técnicas analíticas adequadas. A detecção e quantificação são normalmente realizadas por HPLC-UV acoplado à espectrometria de massa LC-MS | complementadas por RMN para confirmação estrutural. Características cromatográficas | massa molecular | solubilidade e comportamento durante estudos de estabilidade informam limites de aceitação e estratégias de controle no processo de síntese e purificação. A documentação analítica deve seguir diretrizes ICH Q3A e Q3B | incluindo validação de métodos | ensaios de degradação forçada e critérios de liberação de lote.
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