USPUSP-NF
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Palbociclib
C24H29N702 447.54
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.

  1. 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.

  2. 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

USP REFERENCE STANDARDS FOR PURCHASE

USP Palbociclib RS
USP Palbociclib Related Compound A RS
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