Clavulanate Potassium EP Impurity B CAS 96681-85-5

Description

The occurrence of Clavulanate Potassium EP Impurity B is closely related to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Clavulanate Potassium EP Impurity B (CAS 96681-85-5) is a certified pharmaceutical impurity reference standard with the molecular formula C11H16N2O4 and a molecular weight of 240.26 g/mol.

Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Clavulanate Potassium EP Impurity B is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 240.26 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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), Clavulanate Potassium EP Impurity B 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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