Nizatidine impurity 16 CAS CATO-C4X-138016

Description

Compared with other compounds in its class, the molecular weight of 389.45 g/mol gives Nizatidine impurity 16 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Nizatidine impurity 16 (CAS CATO-C4X-138016, C12H19N7O4S2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Nizatidine impurity 16 (C12H19N7O4S2) 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 Nizatidine impurity 16 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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