Ursodeoxycholic Acid EP Impurity B CAS 81-25-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.81-25-4
Molecular FormulaC24H40O5
Molecular Weight408.57 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ursodeoxycholic Acid EP Impurity B CAS 81-25-4 chemical structure

Description

As a certified reference material (CRM), Ursodeoxycholic Acid 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.

CATO supplies Ursodeoxycholic Acid EP Impurity B (CAS 81-25-4), a pharmacopoeial impurity reference standard (molecular formula C24H40O5, MW 408.57 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, a hydroxyl group, an ether linkage, Ursodeoxycholic Acid EP Impurity B is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 408.57 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 FormulaC24H40O5
Molecular Weight408.57 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>95%
StorageStore at room temperature, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957

Related Ursodeoxycholic Standards

Recommended Standards

Why CATO?