Pemafibrate Impurity 54 CAS CATO-C4X-290354

Description

Compared with other compounds in its class, the molecular weight of 546.65 g/mol gives Pemafibrate Impurity 54 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Pemafibrate Impurity 54 (CAS CATO-C4X-290354), a pharmacopoeial impurity reference standard (molecular formula C32H38N2O6, MW 546.65 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Pemafibrate Impurity 54 (C32H38N2O6) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. 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 546.65 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

As a certified reference material (CRM), Pemafibrate Impurity 54 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

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