Oseltamivir Impurity 35 CAS CATO-C4X-172035

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Oseltamivir Impurity 35.

CATO supplies Oseltamivir Impurity 35 (CAS CATO-C4X-172035), a pharmacopoeial impurity reference standard (molecular formula C16H30N2O4, MW 314.42 g/mol) used for the identification and quantification of trace impurities in APIs.

Oseltamivir Impurity 35 (C16H30N2O4) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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), Oseltamivir Impurity 35 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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