Saxagliptin Impurity 82 CAS CATO-C4X-104982

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-104982
Molecular FormulaC20H27N3O3
Molecular Weight357.45 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Saxagliptin Impurity 82 CAS CATO-C4X-104982 chemical structure

Description

The occurrence of Saxagliptin Impurity 82 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Saxagliptin Impurity 82 (CAS CATO-C4X-104982, C20H27N3O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Saxagliptin Impurity 82 (C20H27N3O3) 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 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).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a certified reference material (CRM), Saxagliptin Impurity 82 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 FormulaC20H27N3O3
Molecular Weight357.45 g/mol
AppearancePale yellow to yellow crystalline powder
Purity≥95%
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
Nitrogen Atoms3

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