Sivelestat sodium Impurity 23 CAS 82185-40-8

Description

The occurrence of Sivelestat sodium Impurity 23 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.

CATO supplies Sivelestat sodium Impurity 23 (CAS 82185-40-8), a pharmacopoeial impurity reference standard (molecular formula C10H12N2O3, MW 208.21 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Sivelestat sodium Impurity 23 (C10H12N2O3) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 208.21 g/mol, it falls into the medium-molecular-weight range. 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.

CATO manufactures Sivelestat sodium Impurity 23 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

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