Fulvestrant EP Impurity C CAS CATO-C4X-19173

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-19173
Molecular FormulaC41H65F5O4S2
Molecular Weight781.07 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fulvestrant EP Impurity C CAS CATO-C4X-19173 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 781.07 g/mol gives Fulvestrant EP Impurity C distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Fulvestrant EP Impurity C (CAS CATO-C4X-19173), a pharmacopoeial impurity reference standard (molecular formula C41H65F5O4S2, MW 781.07 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Fulvestrant EP Impurity C (C41H65F5O4S2) contains a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, a polycyclic aromatic system. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 781.07 g/mol, it falls into the high-molecular-weight range. 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.

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

Molecular FormulaC41H65F5O4S2
Molecular Weight781.07 g/mol
Purity>95%
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 Atoms2

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