Loratadine EP Impurity 39 CAS 609806-38-4

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.609806-38-4
Molecular FormulaC23H25ClN2O4
Molecular Weight428.91 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Loratadine EP Impurity 39 CAS 609806-38-4 chemical structure

Description

CATO supplies Loratadine EP Impurity 39 (CAS 609806-38-4), a pharmacopoeial impurity reference standard (molecular formula C23H25ClN2O4, MW 428.91 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Loratadine EP Impurity 39 (C23H25ClN2O4) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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).

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), Loratadine EP Impurity 39 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 FormulaC23H25ClN2O4
Molecular Weight428.91 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore in a cool place (≤25°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
CAS Registry Year (est.)1985
Halogen ContentCl-containing
Nitrogen Atoms2

Related Loratadine Standards

Recommended Standards

Why CATO?