Spironolactone EP Impurity B CAS CATO-C4X-13452

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-13452
Molecular FormulaC24H31BrO4S
Molecular Weight495.47 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Spironolactone EP Impurity B CAS CATO-C4X-13452 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 Spironolactone EP Impurity B.

CATO supplies Spironolactone EP Impurity B (CAS CATO-C4X-13452), a pharmacopoeial impurity reference standard (molecular formula C24H31BrO4S, MW 495.47 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Spironolactone EP Impurity B (C24H31BrO4S) is characterized by a flavonoid core, a sulfone group, a hydroxyl group, an ether linkage, bromine substitution. 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. 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.

As a certified reference material (CRM), Spironolactone EP Impurity B 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 FormulaC24H31BrO4S
Molecular Weight495.47 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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentBr-containing
Sulfur Atoms1

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