Diclofenac dodecyl ester é uma impureza lipofílica associada a processos de esterificação e transesterificação do diclofenaco | cuja presença pode alterar o perfil de impurezas e a determinação de teor em matérias primas e formulações. Esta impureza tende a formar-se por reações secundárias com álcoois de cadeia longa ou por contaminação cruzada | exigindo monitoramento rigoroso por HPLC-UV com métodos validados e confirmação por UHPLC-MS e RMN para identificação estrutural. Estudos forçados e de estabilidade avaliam sua geração ao longo do tempo | enquanto controles de processo | purificação por cromatografia e especificações por ICH Q3A ajudam a estabelecer limites aceitáveis e estratégias de mitigação.
Referências
“Improved Ex Vivo Transcutaneous Permeation of Diclofenac from Solid Lipid Nanoparticles in the Presence of Novel Long-Chain Alkyl Esters of PABA.†Journal of Dispersion Science and Technology, 2011, www.tandfonline.com/doi/abs/10.1080/01932691.2010.498248.Sallmann, Alfred R. “The History of Diclofenac.†The American Journal of Medicine, vol. 80, no. 4, Apr. 1986, pp. 29–33, https://doi.org/10.1016/0002-9343(86)90076-8.
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