Pioglitazone impurity 40 CAS 1333112-55-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1333112-55-2
Molecular FormulaC18H22N2O2
Molecular Weight298.38 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pioglitazone impurity 40 CAS 1333112-55-2 chemical structure

Description

Pioglitazone impurity 40 (CAS 1333112-55-2) is a certified pharmaceutical impurity reference standard with the molecular formula C18H22N2O2 and a molecular weight of 298.38 g/mol.

Pioglitazone impurity 40 (C18H22N2O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

As a certified reference material (CRM), Pioglitazone impurity 40 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.

Physical & Chemical Properties

Molecular FormulaC18H22N2O2
Molecular Weight298.38 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Nitrogen Atoms2

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