Prucalopride-N-Galactopyranoside é uma impureza glicossilada associada ao processo de síntese de prucalopride | formada por reação secundária ou por degradação durante etapas aquosas. De caráter polar e massa molecular aumentada | afeta perfil de pureza e requer monitoramento rigoroso em controle de qualidade. Detectável e quantificável por HPLC com detecção UV | LC-MS para confirmação de massa e RMN para caracterização estrutural | apresenta tempo de retenção reduzido em fase reversa e sinais diagnósticos em espectrometria de massas. Recomenda-se inclusão em especificações de lote | limites aceitos baseados em toxicidade e validação de métodos analíticos e procedimentos de purificação para mitigação.
Referências
Tameez Ud Din, Asim, et al. “Clinical Efficacy and Safety Profile of Prucalopride in Chronic Idiopathic Constipation.†Cureus, 4 Apr. 2019, 10.7759/cureus.4382.
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