Pitolisant Impurity 45 CAS CATO-C4X-252045

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-252045
Molecular FormulaC29H42Cl2NO2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitolisant Impurity 45 CAS CATO-C4X-252045 chemical structure

Description

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Pitolisant Impurity 45 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 543.01 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

Pitolisant Impurity 45 (CAS CATO-C4X-252045) is a certified pharmaceutical impurity reference standard with the molecular formula C29H42Cl2NO2Cl and a molecular weight of 543.01 g/mol.

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.

As a certified reference material (CRM), Pitolisant Impurity 45 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 FormulaC29H42Cl2NO2 Cl
Molecular Weight543.01 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
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)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

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