Irbesartan Impurity 44 CAS CATO-C4X-166644

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-166644
Molecular FormulaC11H20N2O2
Molecular Weight212.29 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Irbesartan Impurity 44 CAS CATO-C4X-166644 chemical structure

Description

As a certified reference material (CRM), Irbesartan Impurity 44 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 Irbesartan Impurity 44 (CAS CATO-C4X-166644), a pharmacopoeial impurity reference standard (molecular formula C11H20N2O2, MW 212.29 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Irbesartan Impurity 44 (C11H20N2O2) is characterized by an amino-acid-derived structure, 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 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.

Physical & Chemical Properties

Molecular FormulaC11H20N2O2
Molecular Weight212.29 g/mol
AppearanceWhite to pale 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)3.0
UV AbsorptionUV-absorbing
Nitrogen Atoms2

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