Enzalutamide Impurity 57 CAS CATO-C4X-101657

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Enzalutamide Impurity 57.

Enzalutamide Impurity 57 (CAS CATO-C4X-101657) is a certified pharmaceutical impurity reference standard with the molecular formula C25H16F6N4OS and a molecular weight of 534.48 g/mol.

Enzalutamide Impurity 57 (C25H16F6N4OS) contains a steroid core, an amide group, sulfur-containing functionality, a hydroxyl group, an ether linkage, fluorine substitution. Halogen substitution raises its density and boiling point; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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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