Racecadotril EP Impurity E CAS 5669-19-2

Description

Compared with other compounds in its class, the molecular weight of 162.19 g/mol gives Racecadotril EP Impurity E distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Racecadotril EP Impurity E (CAS 5669-19-2), a pharmacopoeial impurity reference standard (molecular formula C10H10O2, MW 162.19 g/mol) used for the identification and quantification of trace impurities in APIs.

Racecadotril EP Impurity E (C10H10O2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. 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), Racecadotril EP Impurity E 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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