Fulvestrant impurity 57 CAS CATO-C4X-191757

Description

Compared with other compounds in its class, the molecular weight of 753.06 g/mol gives Fulvestrant impurity 57 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Fulvestrant impurity 57 (CAS CATO-C4X-191757), a pharmacopoeial impurity reference standard (molecular formula C49H68O6, MW 753.06 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Fulvestrant impurity 57 (C49H68O6) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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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