Nilotinib EP Impurity F는 Nilotinib Ethylimidazole Analog로도 불리며, ATP 경쟁적 BCR-ABL 티로신 키나아제 억제제인 닐로티닙과 구조적으로 관련된 공정 불순물이다. 이는 단순 분해산물이 아니라 합성 경로 개발 중 또는 헤테로고리 형성이 불완전할 때 생성될 수 있는 알킬화 이미다졸 유도체에 해당한다. CAS 2119583-24-1, 분자식 C29H24F3N7O, 분자량 543.54 g/mol을 가지며, 동정 및 정량에는 LC-MS/MS, 고분해능 MS, HPLC 기반 불순물 프로파일링이 필요하고, 분리 가능할 경우 NMR 확인이 요구된다. 평가는 ICH Q3A 및 관련 규제 기준에 따른다.
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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