Bumetanide Impurity 82 CAS CATO-C4X-198682

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Bumetanide Impurity 82.

CATO supplies Bumetanide Impurity 82 (CAS CATO-C4X-198682), a pharmacopoeial impurity reference standard (molecular formula C13H12N2O8S2, MW 388.37 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Bumetanide Impurity 82 (C13H12N2O8S2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 388.37 g/mol, it falls into the moderately-high-molecular-weight range. 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), Bumetanide Impurity 82 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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