Pitolisant Impurity 49 CAS CATO-C4X-252049

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-252049
Molecular FormulaC20H33ClNO2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitolisant Impurity 49 CAS CATO-C4X-252049 chemical structure

Description

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 supplies Pitolisant Impurity 49 (CAS CATO-C4X-252049), a pharmacopoeial impurity reference standard (molecular formula C20H33ClNO2I, MW 481.84 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C20H33ClNO2I, Pitolisant Impurity 49 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine/iodine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 481.84 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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

Molecular FormulaC20H33ClNO2 I
Molecular Weight481.84 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity≥95%
StorageStore at room temperature, 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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl/I-containing
Nitrogen Atoms1

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