Ursodeoxycholic Acid Impurity 71 CAS 69519-35-3

Description

The occurrence of Ursodeoxycholic Acid Impurity 71 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.

CATO supplies Ursodeoxycholic Acid Impurity 71 (CAS 69519-35-3), a pharmacopoeial impurity reference standard (molecular formula C26H44O4, MW 420.63 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Ursodeoxycholic Acid Impurity 71 (C26H44O4) is characterized by a steroid core, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

As a certified reference material (CRM), Ursodeoxycholic Acid Impurity 71 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

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