Fulvestrant impurity 32 CAS CATO-C4X-191732

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-191732
Molecular FormulaC32H47F5O3S
Molecular Weight606.77 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fulvestrant impurity 32 CAS CATO-C4X-191732 chemical structure

Description

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.

As a process- or degradation-related impurity, Fulvestrant impurity 32 (CAS CATO-C4X-191732, C32H47F5O3S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C32H47F5O3S, Fulvestrant impurity 32 contains a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, a polycyclic aromatic system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 606.77 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.

Physical & Chemical Properties

Molecular FormulaC32H47F5O3S
Molecular Weight606.77 g/mol
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)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Sulfur Atoms1

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