Alogliptin Impurity 1 CAS 1638544-64-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1638544-64-5
Molecular FormulaC18H21N5O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Alogliptin Impurity 1 CAS 1638544-64-5 chemical structure

Description

As a process- or degradation-related impurity, Alogliptin Impurity 1 (CAS 1638544-64-5, C18H21N5O2C7H6O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C18H21N5O2C7H6O2, Alogliptin Impurity 1 contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 461.52 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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), Alogliptin Impurity 1 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 FormulaC18H21N5O2 C7H6O2
Molecular Weight461.52 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore in a cool place (≤25°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)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1993
Nitrogen Atoms5

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