Escitalopram EP Impurity I (CAS 1370643-22-3) é uma impureza relacionada ao processo de síntese e à degradação do escitalopram | crítica para o controle de qualidade farmacêutico. Sua caracterização requer métodos analíticos robustos | incluindo HPLC com detecção por DAD e confirmação por LC-MS/MS ou espectrometria de massas de alta resolução. Parâmetros chave incluem tempo de retenção | massa exata e perfil de fragmentação. A quantificação precisa | os limites de aceitabilidade e a investigação de tendências são estabelecidos conforme a monografia EP e as estratégias de validação de método | para garantir conformidade regulatória e segurança do produto final.
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