Dexmedetomidine Impurity 80 CAS CATO-C4X-123080

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Dexmedetomidine Impurity 80.

Dexmedetomidine Impurity 80 (CAS CATO-C4X-123080) is a certified pharmaceutical impurity reference standard with the molecular formula C4H5N3O2 and a molecular weight of 127.10 g/mol.

Dexmedetomidine Impurity 80 (C4H5N3O2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 Dexmedetomidine Impurity 80 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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