Desloratadine Impurity 64 CAS CATO-C4X-143064

Purity 95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-143064
Molecular FormulaC19H18ClN3O2
Molecular Weight355.82 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Desloratadine Impurity 64 CAS CATO-C4X-143064 chemical structure

Description

The occurrence of Desloratadine Impurity 64 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Desloratadine Impurity 64 (CAS CATO-C4X-143064) is a certified pharmaceutical impurity reference standard with the molecular formula C19H18ClN3O2 and a molecular weight of 355.82 g/mol.

Desloratadine Impurity 64 (C19H18ClN3O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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), Desloratadine Impurity 64 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 FormulaC19H18ClN3O2
Molecular Weight355.82 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms3

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