Obeticholic Acid Impurity 19 CAS 863239-60-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.863239-60-5
Molecular FormulaC28H47NO5
Molecular Weight477.68 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Obeticholic Acid Impurity 19 CAS 863239-60-5 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.

As a process- or degradation-related impurity, Obeticholic Acid Impurity 19 (CAS 863239-60-5, C28H47NO5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Obeticholic Acid Impurity 19 (C28H47NO5) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC28H47NO5
Molecular Weight477.68 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>95%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1987
Nitrogen Atoms1

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