Ketotifen Impurity 35 CAS CATO-C4X-204635

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-204635
Molecular FormulaC19H19NO2S
Molecular Weight325.42 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ketotifen Impurity 35 CAS CATO-C4X-204635 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.

CATO supplies Ketotifen Impurity 35 (CAS CATO-C4X-204635), a pharmacopoeial impurity reference standard (molecular formula C19H19NO2S, MW 325.42 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, Ketotifen Impurity 35 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 325.42 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

Physical & Chemical Properties

Molecular FormulaC19H19NO2S
Molecular Weight325.42 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1
Sulfur Atoms1

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