Pitolisant impurity 21 CAS CATO-C4X-252021

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Pitolisant impurity 21.

As a process- or degradation-related impurity, Pitolisant impurity 21 (CAS CATO-C4X-252021, C10H14O3S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Pitolisant impurity 21 (C10H14O3S) contains a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. It is notably hygroscopic, 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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