Darolutamide impurity 8 CAS CATO-C4X-31068

Description

Compared with other compounds in its class, the molecular weight of 641.51 g/mol gives Darolutamide impurity 8 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Darolutamide impurity 8 (CAS CATO-C4X-31068), a pharmacopoeial impurity reference standard (molecular formula C31H26Cl2N10O2, MW 641.51 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Darolutamide impurity 8 (C31H26Cl2N10O2) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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

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