Ribociclib Impurity 37

Quantification of ribociclib in dried blood spots by LC-​MS​/MS: Method development and clinical validation
By Braal C Louwrens; Lam Mei H; Bos Monique E M M; Mathijssen Ron H J; de Bruijn Peter; Rienks Tineke; van Tilborg Claudia J; Heuts Wendy; Heijns Joan B; Koolen Stijn L W
From Journal of pharmaceutical and biomedical analysis (2021), 201, 114118

Ribociclib Impurity 37 is chemically (2-chloro-7-cyclopentyl-7H-pyrrolo[2,3-d]pyrimidin-6-yl)methyl 2-chloro-7-cyclopentyl-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylate. Ribociclib Impurity 37 is supplied with detailed characterization data compliant with regulatory guideline. Ribociclib Impurity 37 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 Ribociclib.

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.