| CAS No. | 1812193-01-3 |
| Molecular Formula | C18H20FN5O2 |
| Molecular Weight | 357.38 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a certified reference material (CRM), Trelagliptin Impurity 53 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.
Trelagliptin Impurity 53 (CAS 1812193-01-3) is a certified pharmaceutical impurity reference standard with the molecular formula C18H20FN5O2 and a molecular weight of 357.38 g/mol.
Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Trelagliptin Impurity 53 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 357.38 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
| Molecular Formula | C18H20FN5O2 |
| Molecular Weight | 357.38 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1995 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 5 |