Obeticholic Acid Impurity 17 CAS 459789-98-1

Description

The occurrence of Obeticholic Acid Impurity 17 is closely related to a steroid core, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Obeticholic Acid Impurity 17 (CAS 459789-98-1) is a certified pharmaceutical impurity reference standard with the molecular formula C28H48O4 and a molecular weight of 448.68 g/mol.

Owing to a steroid core, a hydroxyl group, an ether linkage, Obeticholic Acid Impurity 17 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 448.68 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.

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.

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

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