2119583-24-1Nilotinib EP Impurity F

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Catalogue No.:	VE008151
CAS No.:	2119583-24-1
Mol. Formula:	C29H24F3N7O
Mol. Weight:	543.54 g/mol

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Additional information on CAS 2119583-24-1

Parent drug

Nilotinib

IUPAC Name

N-(3-(4-Ethyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-4-methyl-3-(4-(pyridin-3-yl)pyrimidin-2-ylamino)benzamide

Synonyms

N/A

Smiles

CCC1=CN(C=N1)C2=CC(=CC(=C2)NC(=O)C3=CC(=C(C=C3)C)NC4=NC=CC(=N4)C5=CN=CC=C5)C(F)(F)F

InChI

InChI=1S/C29H24F3N7O/c1-3-22-16-39(17-35-22)24-13-21(29(30,31)32)12-23(14-24)36-27(40)19-7-6-18(2)26(11-19)38-28-34-10-8-25(37-28)20-5-4-9-33-15-20/h4-17H,3H2,1-2H3,(H,36,40)(H,34,37,38)

Description

Nilotinib EP Impurity F, also designated Nilotinib Ethylimidazole Analog, is a structurally related process impurity of the ATP-competitive BCR-ABL tyrosine kinase inhibitor nilotinib. It is consistent with an alkylated imidazole derivative arising during synthetic route development or incomplete heterocycle construction, rather than a simple degradant. With CAS 2119583-24-1, molecular formula C29H24F3N7O, and molecular weight 543.54 g/mol, it requires orthogonal characterization by LC-MS/MS, high-resolution MS, and impurity profiling HPLC, with NMR confirmation when isolable. Its presence is assessed under impurity control expectations, including ICH Q3A and related regulatory specifications.

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