Budesonide Impurity 63 CAS CATO-C4X-138963

Description

The occurrence of Budesonide Impurity 63 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 Budesonide Impurity 63 (CAS CATO-C4X-138963), a pharmacopoeial impurity reference standard (molecular formula C21H26O3, MW 326.43 g/mol) used for the identification and quantification of trace impurities in APIs.

Budesonide Impurity 63 (C21H26O3) 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), Budesonide Impurity 63 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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