(S)-4-[4-(Dimethylamino)-1-(4-fluorophenyl)-1-hydroxybutyl]-3-(hydroxymethyl)-benzonitrile Di-p-toluoyl-D-tartrate Salt
Sinônimos
Citalopram Dihydroxy Impurity
Descrição
O composto relacionado A do escitalopram (CAS 128173-53-5) | também referido como impureza dihidroxilada do citalopram | é uma impureza relevante para controle de qualidade e estudos de estabilidade. Caracteriza-se por modificação funcional que altera polaridade e perfil de absorção | exigindo técnicas analíticas sensíveis para identificação e quantificação | como HPLC com detecção UV | LC-MS e RMN para elucidação estrutural. Sua formação é frequentemente associada a reações de oxidação durante síntese ou armazenamento | portanto procedimentos de controle de processo e limites de especificação alinhados a ICH Q3A/Q3B são recomendados. A avaliação robusta desta impureza é essencial para garantia de qualidade do material farmacêutico.
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