Nilotinib EP Impurity H, também denominada Nilotinib Regio Isomer Impurity, é um isómero posicional do inibidor de quinase nilotinib, com substituição pirimidínica, associado a vias alternativas de arilação ou ciclização durante a síntese. Não se trata de um simples produto de degradação, mas de uma impureza de प्रक्रिया estruturalmente relacionada que exige identificação ortogonal. O CAS 641571-15-5 corresponde a C28H22F3N7O, massa molecular 529.52 g/mol. Como isómeros de regio podem coeluir com o fármaco em HPLC convencional, a caracterização normalmente recorre a LC-MS/MS, MS de alta resolução e confirmação por RMN. O seu controlo enquadra-se em especificações de impurezas e avaliação toxicológica.
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 Hughes, Timothy, et al. “Impact of Baseline BCR-ABL Mutations on Response to Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase.” Journal of Clinical Oncology, vol. 27, no. 25, Sept. 2009, pp. 4204–10
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