Pioglitazone impurity 28 CAS 5408-74-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.5408-74-2
Molecular FormulaC9H11N
Molecular Weight133.19 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pioglitazone impurity 28 CAS 5408-74-2 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 Pioglitazone impurity 28.

As a process- or degradation-related impurity, Pioglitazone impurity 28 (CAS 5408-74-2, C9H11N) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Pioglitazone impurity 28 (C9H11N) contains a nitrogen-containing heterocyclic scaffold, a nitrile group. Its physicochemical properties are representative of its class; 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.

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 FormulaC9H11N
Molecular Weight133.19 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in methanol, acetonitrile, DMSO
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958
Nitrogen Atoms1

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