Enzalutamide Impurity 40 CAS 3079438-61-9

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 40.

As a process- or degradation-related impurity, Enzalutamide Impurity 40 (CAS 3079438-61-9, C9H3F3N2S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, sulfur-containing functionality, fluorine substitution, Enzalutamide Impurity 40 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 228.19 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

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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