Alogliptin Impurity 19 CAS CATO-C4X-109919

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-109919
Molecular FormulaC19H24N4O4
Molecular Weight372.42 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Alogliptin Impurity 19 CAS CATO-C4X-109919 chemical structure

Description

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 process- or degradation-related impurity, Alogliptin Impurity 19 (CAS CATO-C4X-109919, C19H24N4O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Alogliptin Impurity 19 (C19H24N4O4) contains a flavonoid 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 presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC19H24N4O4
Molecular Weight372.42 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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms4

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