N-Nitroso Ebastine EP Impurity C CAS CATO-C4X-202923

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-202923
Molecular FormulaC18H20N2O2
Molecular Weight296.36 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

N-Nitroso Ebastine EP Impurity C CAS CATO-C4X-202923 chemical structure

Description

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.

CATO supplies N-Nitroso Ebastine EP Impurity C (CAS CATO-C4X-202923), a pharmacopoeial impurity reference standard (molecular formula C18H20N2O2, MW 296.36 g/mol) used for the identification and quantification of trace impurities in APIs.

N-Nitroso Ebastine EP Impurity C (C18H20N2O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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).

As a certified reference material (CRM), N-Nitroso Ebastine EP Impurity C 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 FormulaC18H20N2O2
Molecular Weight296.36 g/mol
AppearancePale yellow to yellow crystalline powder
Purity≥95%
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
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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