Topiramate Impurity 28 CAS 53209-16-8

Description

The occurrence of Topiramate Impurity 28 is closely related to a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Topiramate Impurity 28 (CAS 53209-16-8) is a certified pharmaceutical impurity reference standard with the molecular formula C14H24O9S and a molecular weight of 368.40 g/mol.

Based on its molecular formula C14H24O9S, Topiramate Impurity 28 contains a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 368.40 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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), Topiramate Impurity 28 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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