Gliclazide EP Impurity A CAS 70-55-3

Description

The occurrence of Gliclazide EP Impurity A is closely related to an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Gliclazide EP Impurity A (CAS 70-55-3) is a certified pharmaceutical impurity reference standard with the molecular formula C7H9NO2S and a molecular weight of 171.22 g/mol.

Owing to an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system, Gliclazide EP Impurity A is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 171.22 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), Gliclazide EP Impurity A 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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