Budesonide Impurity 28 (Mixture of Diastereomers) CAS 2408495-96-3

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Budesonide Impurity 28 (Mixture of Diastereomers).

CATO supplies Budesonide Impurity 28 (Mixture of Diastereomers) (CAS 2408495-96-3), a pharmacopoeial impurity reference standard (molecular formula C29H40O7, MW 500.62 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system, Budesonide Impurity 28 (Mixture of Diastereomers) is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 500.62 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 28 (Mixture of Diastereomers) 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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