Fulvestrant impurity 56 CAS CATO-C4X-191756

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-191756
Molecular FormulaC31H47BrO3
Molecular Weight547.61 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fulvestrant impurity 56 CAS CATO-C4X-191756 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Fulvestrant impurity 56.

Fulvestrant impurity 56 (CAS CATO-C4X-191756) is a certified pharmaceutical impurity reference standard with the molecular formula C31H47BrO3 and a molecular weight of 547.61 g/mol.

The molecular framework of Fulvestrant impurity 56 (C31H47BrO3) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, bromine substitution, a polycyclic aromatic system. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

CATO manufactures Fulvestrant impurity 56 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC31H47BrO3
Molecular Weight547.61 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentBr-containing

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