Nilotinib EP Impurity E, também designada Desmethylimidazole Nilotinib, é uma impureza de प्रक्रिया definida do inibidor de quinase nilotinib, originada comumente por desalquilação sintética ou formação incompleta do heterociclo durante a via de fabricação. É identificada pelo CAS 2119583-26-3 e possui fórmula molecular C27H20F3N7O, correspondente a massa molecular de 515.49 g/mol. Estruturalmente preserva o núcleo 2-fenilamino pirimidina e o motivo imidazólico substituído, porém com padrão de N-alquilação distinto do fármaco. A caracterização geralmente requer LC-MS/MS, espectrometria de massas de alta resolução e perfis ortogonais por HPLC, com RMN para confirmação estrutural sob referenciais farmacopeicos e ICH.
Referências
Kondra, S. B., et al. “A Validated Stability-Indicative UPLC Method for Nilotinib Hydrochloride for the Determination of Process-Related and Degradation Impurities.” Journal of Chromatographic Science, vol. 52, no. 8, Sept. 2013, pp. 880–85, https://doi.org/10.1093/chromsci/bmt134.?
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