Impureza Escitalopram J | identificada como ácido p-toluenossulfônico (p-Toluenesulfonic Acid) | CAS 104-15-4 | é uma impureza orgânica observada no processo de fabricação do escitalopram. Caracteriza-se por alta polaridade relativa e comportamento retentivo pronunciado em cromatografia reversa | exigindo condições analíticas otimizadas para separação clara do princípio ativo. Sua presença afeta o perfil de pureza e exige monitoramento por HPLC com detecção UV complementada por LC-MS para confirmação de massa e NMR para elucidação estrutural. Controlos analíticos robustos e limites de especificação baseados em guia regulatório minimizam riscos toxicológicos e garantem conformidade do lote.
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