Benzamide, 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-, monohydrochloride, monohydrate;
4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-{[4-(pyridin-3-yl)pyrimidin-2-yl]amino}benzamide hydrochloride monohydrate [923288-90-8]
BRIEFING
Nilotinib Hydrochloride. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is being proposed. The proposal for this drug substance which appeared in PF 44(3) [May–June 2018] under the article title Nilotinib has been canceled and is replaced with a new proposal under the updated article title Nilotinib Hydrochloride. The liquid chromatographic procedures used in the Assay and the test for Organic Impurities are based on analyses performed with the YMC-Pack ODS-AQ brand of column with L1 packing. The typical retention time for nilotinib is about 10 min.
Description and solubility information: White to slightly yellowish or slightly greenish-yellowish solid. Decomposes prior to melting. Slightly soluble in ethanol, in methanol, and in isopropanol; very slightly soluble in water.
(SM3: R. Fales)
Correspondence Number—C323998