Ursodeoxycholic Acid Impurity N3 CAS 28083-34-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.28083-34-3
Molecular FormulaC24H40O3
Molecular Weight376.57 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ursodeoxycholic Acid Impurity N3 CAS 28083-34-3 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 Ursodeoxycholic Acid Impurity N3.

As a process- or degradation-related impurity, Ursodeoxycholic Acid Impurity N3 (CAS 28083-34-3, C24H40O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Ursodeoxycholic Acid Impurity N3 (C24H40O3) contains a steroid core, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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), Ursodeoxycholic Acid Impurity N3 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 FormulaC24H40O3
Molecular Weight376.57 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.)1965

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