Apalutamide Impurity 101 CAS CATO-C4X-2749101

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Apalutamide Impurity 101.

CATO supplies Apalutamide Impurity 101 (CAS CATO-C4X-2749101), a pharmacopoeial impurity reference standard (molecular formula C16H4F6N6S2, MW 458.36 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C16H4F6N6S2, Apalutamide Impurity 101 contains a nitrogen-containing heterocyclic scaffold, a nitrile group, sulfur-containing functionality, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 458.36 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

As a certified reference material (CRM), Apalutamide Impurity 101 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

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