Olopatadine Impurity N3 CAS 113835-76-0

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.113835-76-0
Molecular FormulaC21H25NO2
Molecular Weight323.43 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Olopatadine Impurity N3 CAS 113835-76-0 chemical structure

Description

As a certified reference material (CRM), Olopatadine Impurity N3 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.

CATO supplies Olopatadine Impurity N3 (CAS 113835-76-0), a pharmacopoeial impurity reference standard (molecular formula C21H25NO2, MW 323.43 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Olopatadine Impurity N3 (C21H25NO2) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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.

Physical & Chemical Properties

Molecular FormulaC21H25NO2
Molecular Weight323.43 g/mol
AppearancePale yellow to yellow crystalline powder
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
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1989
Nitrogen Atoms1

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