Alogliptin Impurity 15 CAS CATO-C4X-109915

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-109915
Molecular FormulaC18H21N5O2
Molecular Weight339.39 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Alogliptin Impurity 15 CAS CATO-C4X-109915 chemical structure

Description

As a certified reference material (CRM), Alogliptin Impurity 15 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.

As a process- or degradation-related impurity, Alogliptin Impurity 15 (CAS CATO-C4X-109915, C18H21N5O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Alogliptin Impurity 15 (C18H21N5O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, 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.

Physical & Chemical Properties

Molecular FormulaC18H21N5O2
Molecular Weight339.39 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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms5

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