Pitolisant Impurity 46 CAS CATO-C4X-252046

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-252046
Molecular FormulaC18H18Cl2O2
Molecular Weight337.24 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitolisant Impurity 46 CAS CATO-C4X-252046 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 337.24 g/mol gives Pitolisant Impurity 46 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Pitolisant Impurity 46 (CAS CATO-C4X-252046, C18H18Cl2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a steroid core, a hydroxyl group, an ether linkage, chlorine substitution, Pitolisant Impurity 46 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 337.24 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

As a certified reference material (CRM), Pitolisant Impurity 46 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC18H18Cl2O2
Molecular Weight337.24 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing

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