N-Nitroso Amoxicillin Impurity J Dimer CAS CATO-C4X-114878

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 Amoxicillin Impurity J Dimer.

CATO supplies N-Nitroso Amoxicillin Impurity J Dimer (CAS CATO-C4X-114878), a pharmacopoeial impurity reference standard (molecular formula C32H37N7O11S2, MW 759.81 g/mol) used for the identification and quantification of trace impurities in APIs.

N-Nitroso Amoxicillin Impurity J Dimer (C32H37N7O11S2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 Amoxicillin Impurity J Dimer 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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