Alectinib Hydrochloride
C30H34N4O2·HCl
519.09
5H-Benzo[b]carbazole-3-carbonitrile, 9-ethyl-6,11-dihydro-6,6-dimethyl-8-[4-(4-morpholinyl)-1-piperidinyl]-11-oxo-, hydrochloride (1:1);
9-Ethyl-6,6-dimethyl-8-(4-morpholinopiperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile hydrochloride [1256589-74-8]
5H-Benzo[b]carbazole-3-carbonitrile, 9-ethyl-6,11-dihydro-6,6-dimethyl-8-[4-(4-morpholinyl)-1-piperidinyl]-11-oxo-, hydrochloride (1:1);
9-Ethyl-6,6-dimethyl-8-(4-morpholinopiperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile hydrochloride [1256589-74-8]
BRIEFING
Alectinib Hydrochloride. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedures used in the Assay and the test for Organic Impurities were validated using the Sunfire C18 brand of column with L1 packing. The typical retention time for alectinib is about 15 min.
Description and Solubility information: White to yellow-white powder with lumps. Soluble in dimethyl sulfoxide.
(SM3: R. Fales)
Case ID—SUB-595