Fulvestrant EP Impurity A CAS 407577-53-1

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.407577-53-1
Molecular FormulaC32H47F5O3S
Molecular Weight606.77 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fulvestrant EP Impurity A CAS 407577-53-1 chemical structure

Description

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.

Fulvestrant EP Impurity A (CAS 407577-53-1) is a certified pharmaceutical impurity reference standard with the molecular formula C32H47F5O3S and a molecular weight of 606.77 g/mol.

Owing to a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, a polycyclic aromatic system, Fulvestrant EP Impurity A is typically off-white to pale yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 606.77 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

As a certified reference material (CRM), Fulvestrant EP Impurity A meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC32H47F5O3S
Molecular Weight606.77 g/mol
Purity>90%
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
CAS Registry Year (est.)2025
Halogen ContentF-containing
Sulfur Atoms1

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