Obeticholic Acid Impurity 13 CAS 1537866-49-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1537866-49-1
Molecular FormulaC26H46O3
Molecular Weight406.64 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Obeticholic Acid Impurity 13 CAS 1537866-49-1 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.

Obeticholic Acid Impurity 13 (CAS 1537866-49-1) is a certified pharmaceutical impurity reference standard with the molecular formula C26H46O3 and a molecular weight of 406.64 g/mol.

Owing to a steroid core, a hydroxyl group, an ether linkage, Obeticholic Acid Impurity 13 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 406.64 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC26H46O3
Molecular Weight406.64 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
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)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1992

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