Fulvestrant impurity 41 CAS CATO-C4X-191741

Description

The occurrence of Fulvestrant impurity 41 is closely related to a steroid core, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Fulvestrant impurity 41 (CAS CATO-C4X-191741), a pharmacopoeial impurity reference standard (molecular formula C29H43ClO3, MW 475.10 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C29H43ClO3, Fulvestrant impurity 41 contains a steroid core, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 475.10 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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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