Ursodeoxycholic Acid EP Impurity A CAS 474-25-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.474-25-9
Molecular FormulaC24H40O4
Molecular Weight392.57 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ursodeoxycholic Acid EP Impurity A CAS 474-25-9 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.

Ursodeoxycholic Acid EP Impurity A (CAS 474-25-9) is a certified pharmaceutical impurity reference standard with the molecular formula C24H40O4 and a molecular weight of 392.57 g/mol.

Owing to a steroid core, a hydroxyl group, an ether linkage, Ursodeoxycholic Acid EP Impurity A is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 392.57 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.

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 FormulaC24H40O4
Molecular Weight392.57 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>95%
StorageStore at room temperature, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
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

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