Etoricoxib Impurity D (CAS 221615-75-4) é uma impureza relacionada observada em rotas de síntese e nos estudos de degradação do etoricoxib, cujo perfil químico é confirmado por LC-MS e espectros 1H/13C NMR. Caracteriza-se por tempo de retenção distinto em HPLC e parâmetros de fragmentação consistentes com a estrutura proposta. É monitorada por métodos validados com determinação de LOD e LOQ, limites de especificação e testes de estabilidade em diferentes temperaturas e pH. A investigação analítica inclui identificação da via de formação, medidas de controle de processo e estratégias de redução para atender requisitos regulatórios ICH e garantir qualidade do produto final.
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