Diclofenac Impurity 3 (CAS 146607-19-4) é uma impureza identificada em matérias-primas e formulados contendo diclofenaco | relevante para controles de qualidade e cumprimento regulatório. Caracteriza-se por presença em níveis traços originados de vias sintéticas e degradação | exigindo caracterização estrutural e quantificação por técnicas analíticas robustas | como HPLC com detecção UV e LC-MS para confirmação de massa. O monitoramento desta impureza suporta avaliações de pureza | estabilidade e segurança | orientando limites segundo diretrizes ICH e procedimentos de liberação. Fornecemos dados cromatográficos e certificados de análise para auxiliar no estabelecimento de especificações e estratégias de controle de processo.
Referências
Goodwin, B. L. Handbook of Biotransformations of Aromatic Compounds. Nov. 2004, https://doi.org/10.1201/9780203641965.?Europe PMC. “Europe PMC.†Europepmc.org, 2016, europepmc.org/article/med/2670397.
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