Pyrido[2,3-d] pyrimidin-7(8H)-one, 6-acetyl-8-cyclopentyl-5-methyl-2-[[5-(1-piperazinyl)-2-pyridinyl]amino]-;
6-Acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d] pyrimidin-7(8H)-one [571190-30-2]
BRIEFING
Palbociclib. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedure in the Assay was validated using the Kromasil C18 brand of column with L1 packing. The typical retention time for palbociclib is about 3 min.
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The liquid chromatographic procedure in the Organic Impurities test was validated using the ACE C18-PFP brand of column with L1 packing. The typical retention time for palbociclib is about 24 min.
This monograph is contingent on FDA approval of a product that meets the proposed monograph specifications. Please see the Pending Monograph Guideline for additional information.
Description and Solubility information: Yellow to orange colored powder. Sparingly soluble in 0.1 N hydrochloric acid solution; very slightly soluble in dimethyl sulfoxide; slightly soluble to practically insoluble in dichloromethane; practically insoluble in water.
(SM3: R. Muppa)
Case ID—SUB-546