Pitolisant Impurity 1 CAS CATO-C4X-25201

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-25201
Molecular FormulaC17H26ClNO3
Molecular Weight327.85 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitolisant Impurity 1 CAS CATO-C4X-25201 chemical structure

Description

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

CATO supplies Pitolisant Impurity 1 (CAS CATO-C4X-25201), a pharmacopoeial impurity reference standard (molecular formula C17H26ClNO3, MW 327.85 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C17H26ClNO3, Pitolisant Impurity 1 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 327.85 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 FormulaC17H26ClNO3
Molecular Weight327.85 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
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)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

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