| CAS No. | CATO-C4X-104982 |
| Molecular Formula | C20H27N3O3 |
| Molecular Weight | 357.45 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
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.
| Molecular Formula | C20H27N3O3 |
| Molecular Weight | 357.45 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | ≥95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 3 |