Nilotinib EP Impurity Fは、Nilotinib Ethylimidazole Analogとも呼ばれ、ATP競合型BCR-ABLチロシンキナーゼ阻害薬ニロチニブに構造的に関連する工程由来不純物である。これは単純な分解物ではなく、合成経路の進行中または複素環形成不完全により生じる可能性が高いエチル化イミダゾール誘導体である。CAS 2119583-24-1、分子式C29H24F3N7O、分子量543.54 g/molを有し、同定と定量にはLC-MS/MS、HRMS、HPLCによる不純物プロファイリングが必要で、単離可能な場合はNMR確認を要する。管理はICH Q3A等の規制要件に従う。
References
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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