Prucalopride Impurity 53 CAS CATO-C4X-103853

Description

Compared with other compounds in its class, the molecular weight of 276.80 g/mol gives Prucalopride Impurity 53 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Prucalopride Impurity 53 (CAS CATO-C4X-103853, C13H25ClN2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Prucalopride Impurity 53 (C13H25ClN2O2) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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 Prucalopride Impurity 53 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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