Irbesartan Impurity 43 CAS CATO-C4X-166643

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-166643
Molecular FormulaC11H18N2O
Molecular Weight194.27 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Irbesartan Impurity 43 CAS CATO-C4X-166643 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Irbesartan Impurity 43.

CATO supplies Irbesartan Impurity 43 (CAS CATO-C4X-166643), a pharmacopoeial impurity reference standard (molecular formula C11H18N2O, MW 194.27 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Irbesartan Impurity 43 (C11H18N2O) is characterized by a nitrogen-containing heterocyclic scaffold, 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC11H18N2O
Molecular Weight194.27 g/mol
Purity≥95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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