Pitolisant impurity 4 CAS CATO-C4X-25204

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-25204
Molecular FormulaC9H19NO3S
Molecular Weight221.32 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitolisant impurity 4 CAS CATO-C4X-25204 chemical structure

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 4.

As a process- or degradation-related impurity, Pitolisant impurity 4 (CAS CATO-C4X-25204, C9H19NO3S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Pitolisant impurity 4 (C9H19NO3S) contains an amide group, a sulfone group, a carboxylic acid 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 Pitolisant impurity 4 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

Molecular FormulaC9H19NO3S
Molecular Weight221.32 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)1.0
Nitrogen Atoms1
Sulfur Atoms1

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