Irbesartan impurity 40 CAS CATO-C4X-166640

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-166640
Molecular FormulaC25H25N3O
Molecular Weight383.49 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Irbesartan impurity 40 CAS CATO-C4X-166640 chemical structure

Description

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.

As a process- or degradation-related impurity, Irbesartan impurity 40 (CAS CATO-C4X-166640, C25H25N3O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Irbesartan impurity 40 (C25H25N3O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

Physical & Chemical Properties

Molecular FormulaC25H25N3O
Molecular Weight383.49 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
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)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms3

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