Abemaciclib Impurity 1

Development and validation of a bioanalytical method for the quantification of the CDK4​/6 inhibitors abemaciclib, palbociclib, and ribociclib in human and mouse matrices using liquid chromatography-​tandem mass spectrometry
By Martinez-Chavez, Alejandra; Rosing, Hilde; Hillebrand, Michel; Tibben, Matthijs; Schinkel, Alfred H.; Beijnen, Jos H.
From Analytical and Bioanalytical Chemistry (2019), 411(20), 5331-5345

Abemaciclib Impurity 1 is chemically 5-((4-Ethylpiperazin-1-yl)methyl)pyridin-2-amine. Abemaciclib Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Abemaciclib Impurity 1 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Abemaciclib.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.