N-Nitroso Linagliptin Impurity 112 CAS CATO-C4X-1101112

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including N-Nitroso Linagliptin Impurity 112.

CATO supplies N-Nitroso Linagliptin Impurity 112 (CAS CATO-C4X-1101112), a pharmacopoeial impurity reference standard (molecular formula C21H20N8O3, MW 432.44 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, N-Nitroso Linagliptin Impurity 112 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 432.44 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.

CATO manufactures N-Nitroso Linagliptin Impurity 112 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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