Darolutamide Impurity 12 CAS 2415967-06-3

Description

Compared with other compounds in its class, the molecular weight of 360.84 g/mol gives Darolutamide Impurity 12 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Darolutamide Impurity 12 (CAS 2415967-06-3, C18H21ClN4O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Darolutamide Impurity 12 (C18H21ClN4O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; 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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