Pitolisant impurity 28 CAS CATO-C4X-252028

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-252028
Molecular FormulaC11H24ClNO2
Molecular Weight237.77 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitolisant impurity 28 CAS CATO-C4X-252028 chemical structure

Description

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.

Pitolisant impurity 28 (CAS CATO-C4X-252028) is a certified pharmaceutical impurity reference standard with the molecular formula C11H24ClNO2 and a molecular weight of 237.77 g/mol.

The molecular framework of Pitolisant impurity 28 (C11H24ClNO2) is characterized by an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

Physical & Chemical Properties

Molecular FormulaC11H24ClNO2
Molecular Weight237.77 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityLight-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)0.0
Halogen ContentCl-containing
Nitrogen Atoms1

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