Yuan-Qi Du
2015
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Journal
Journal of China Pharmaceutical University
Abstract
To strengthen the quality control of palbociclib,three related substances were separated from the bulk drug.These substances were identified as 8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl) pyridin-2-yl) amino)pyrido[2,3-d]pyrimidin-7(8H)-one(A),8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridine-2-yl)amino)-6-vinylpyrido[2,3-d]pyrimidin-7(8H)-one(B),tert-butyl4-(6-((6-acetyl-8-cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3-d]pyrimidin-2-yl) amino) pyridin-3-yl) piperazi-ne-1-earboxylate(C).Based on the structures of the impurities,the possible routes to them were discussed,and their structures were elucidated by~1H NMR and MS.