Citalopram Impurity 21 (CAS 1133881-04-5) é uma impureza identificada no processo de síntese e degradação do citalopram | relevante para perfil de impurezas e avaliação de qualidade. Caracteriza-se por propriedades físico-químicas e espectrométricas específicas | detectáveis e quantificáveis por HPLC com detector UV | LC-MS e RMN para confirmação estrutural. A sua presença influencia especificações analíticas e limites de aceitação em estudos de estabilidade e validação de processo. Estratégias de controle incluem otimização de etapas sintéticas | purificação cromatográfica e monitorização por métodos validados. Documentação robusta e investigação de origem são essenciais para conformidade regulatória e garantia da segurança do ingrediente ativo.
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