2119583-26-3Desmethylimidazole Nilotinib

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Catalogue No.:	VE006281
CAS No.:	2119583-26-3
Mol. Formula:	C27H20F3N7O
Mol. Weight:	515.49 g/mol

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Additional information on CAS 2119583-26-3

Parent drug

Nilotinib

IUPAC Name

N-[3-(1H-Imidazol-1-yl)-5-(trifluoromethyl)phenyl]-4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]Benzamide

Synonyms

Nilotinib impurity E; Desmethylimidazole Nilotinib

Smiles

CC1=C(C=C(C=C1)C(=O)NC2=CC(=CC(=C2)C(F)(F)F)N3C=CN=C3)NC4=NC=CC(=N4)C5=CN=CC=C5

Description

Nilotinib EP Impurity E, also designated Desmethylimidazole Nilotinib, is a defined process-related impurity of the kinase inhibitor nilotinib, commonly arising from synthetic desalkylation or incomplete heterocycle formation during route-specific manufacture. It is identified by CAS 2119583-26-3 and has molecular formula C27H20F3N7O, corresponding to a molecular weight of 515.49 g/mol. The structure retains the 2-phenylamino pyrimidine core and substituted imidazole motif, with altered N-alkylation pattern relative to the API. Characterization typically requires LC-MS/MS, high-resolution MS, and orthogonal HPLC impurity profiling, with NMR used for structural confirmation under pharmacopeial and ICH impurity frameworks.

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.?