Nilotinib EP Impurity H, 즉 Nilotinib Regio Isomer Impurity는 피리미딜 치환 키나아제 억제제 nilotinib의 위치 이성질체로서, 합성 과정에서의 대체 아릴화 또는 고리화 경로와 연관된 공정 불순물이다. 이는 단순한 분해 산물이 아니라 구조적으로 유사한 불순물로, 정사법적 동정이 필요하다. CAS 641571-15-5, 분자식 C28H22F3N7O, 분자량 529.52 g/mol이다. 위치 이성질체는 일반 HPLC에서 원물질과 공출될 수 있으므로, LC-MS/MS, 고분해능 MS 및 NMR 확인을 통한 특성 규명이 일반적이다. 규제 측면에서는 불순물 규격, 보고 한계, 독성학적 정당화가 핵심이다.
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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