Abemaciclib Impurity 159 CAS CATO-C4X-2937159

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Abemaciclib Impurity 159.

CATO supplies Abemaciclib Impurity 159 (CAS CATO-C4X-2937159), a pharmacopoeial impurity reference standard (molecular formula C27H34N8, MW 470.61 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Abemaciclib Impurity 159 (C27H34N8) contains a nitrogen-containing heterocyclic scaffold, a nitrile group. The molecule exhibits a degree of unsaturation (DBE) of 15.0, corresponding to approximately 15 ring(s) or double-bond equivalent(s). With a molecular weight of 470.61 g/mol, it falls into the moderately-high-molecular-weight range. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Why CATO?

• ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
• 130,000+ catalog items in stock, COA supplied with every batch
• Worldwide shipping with full export documentation (HS code guidance available)
• Technical support: +86 18665070610 / Nicole.chen@cato-chem.com