Prednisolone impurity 65 CAS 20380-15-8

Description

The occurrence of Prednisolone impurity 65 is closely related to a flavonoid core, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Prednisolone impurity 65 (CAS 20380-15-8), a pharmacopoeial impurity reference standard (molecular formula C22H32O4, MW 360.49 g/mol) used for the identification and quantification of trace impurities in APIs.

Prednisolone impurity 65 (C22H32O4) contains a flavonoid 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.

CATO manufactures Prednisolone impurity 65 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

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