Linagliptin impurity 153 CAS CATO-C4X-1101153

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1101153
Molecular FormulaC51H56N16O4
Molecular Weight957.10 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Linagliptin impurity 153 CAS CATO-C4X-1101153 chemical structure

Description

As a certified reference material (CRM), Linagliptin impurity 153 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, Linagliptin impurity 153 (CAS CATO-C4X-1101153, C51H56N16O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Linagliptin impurity 153 (C51H56N16O4) contains a nitrogen-containing heterocyclic scaffold, 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).

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 FormulaC51H56N16O4
Molecular Weight957.10 g/mol
Purity97%+
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)32.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms16

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