Impureza associada ao Ibuprofeno Lisina (CAS 57469-77-9) refere-se a substâncias relacionadas originadas durante síntese | salificação e armazenamento | incluindo ácido ibuprofeno não convertido | isômeros posicionais | produtos N-acilados de L-lysina | impurezas de processo e degradantes por oxidação ou hidrólise. Estas impurezas afetam pureza | solubilidade e perfil toxicológico e exigem monitorização por HPLC e HPLC quiral | LC-MS | RMN e análise de solventes residuais por GC. O controlo de qualidade quantifica níveis conforme ICH Q3A/Q3B | definindo especificações e limites. Identificação estrutural | estudos de estabilidade e investigação de vias de formação são críticos para mitigação e garantia de conformidade farmacêutica.
Referências
Bushra, R., & Aslam, N. (2010). An Overview of Clinical Pharmacology of Ibuprofen. Oman Medical Journal, 25(3), 155–161. https://doi.org/10.5001/omj.2010.49
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