Biotin Impurity 5 CAS 57229-92-2

Description

The occurrence of Biotin Impurity 5 is closely related to a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Biotin Impurity 5 (CAS 57229-92-2), a pharmacopoeial impurity reference standard (molecular formula C17H22N2O3S, MW 334.43 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C17H22N2O3S, Biotin Impurity 5 contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 334.43 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), Biotin Impurity 5 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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