Fulvestrant Impurity 16 CAS CATO-C4X-191716

Description

The occurrence of Fulvestrant Impurity 16 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Fulvestrant Impurity 16 (CAS CATO-C4X-191716), a pharmacopoeial impurity reference standard (molecular formula C35H60O4Si, MW 572.93 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C35H60O4Si, Fulvestrant Impurity 16 contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 572.93 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), Fulvestrant Impurity 16 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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