Pioglitazone impurity 45 CAS CATO-C4X-138345

Description

Compared with other compounds in its class, the molecular weight of 330.44 g/mol gives Pioglitazone impurity 45 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Pioglitazone impurity 45 (CAS CATO-C4X-138345), a pharmacopoeial impurity reference standard (molecular formula C18H22N2O2S, MW 330.44 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Pioglitazone impurity 45 (C18H22N2O2S) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 330.44 g/mol, it falls into the moderately-high-molecular-weight range. 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.

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

Why CATO?

• ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
• 130,000+ catalog items in stock, COA supplied with every batch
• Worldwide shipping with full export documentation (HS code guidance available)
• Technical support: +86 18665070610 / Nicole.chen@cato-chem.com