Sitagliptin Impurity N53 CAS 2379621-81-3
| CAS No. | 2379621-81-3 |
| Molecular Formula | C25H26F6N2O5 |
| Molecular Weight | 548.48 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Sitagliptin Impurity N53 (C25H26F6N2O5) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
As a process- or degradation-related impurity, Sitagliptin Impurity N53 (CAS 2379621-81-3, C25H26F6N2O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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), Sitagliptin Impurity N53 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 Formula | C25H26F6N2O5 |
| Molecular Weight | 548.48 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°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.) | 1999 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 2 |
Related Sitagliptin Standards
- Sitagliptin impurity 113 (CAS CATO-C4X-1144113)
- Sitagliptin Impurity 2 (CAS 769195-20-2)
- Sitagliptin Tablets EP Impurity FP-A (CAS 2088771-60-0)
- Sitagliptin Impurity 165 (CAS CATO-C4X-1144165)
- Sitagliptin Impurity 97 (CAS 1169707-29-2)
- Sitagliptin Impurity 22 (CAS 486460-23-5)
- Sitagliptin Impurity 106 (CAS CATO-C4X-1144106)
- Sitagliptin Impurity 149 (CAS CATO-C4X-1144149)
Recommended Standards
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- Puerarin 6"-O-xyloside (CAS 114240-18-5)
- Isosorbide Dinitrate 19 (CAS 1932354-37-4)
- Nintedanib Impurity 22 (CAS 262368-30-9)
- Perampanel Impurity 44 (CAS CATO-C4X-243044)
- (S)-2-Fluoro-1-(3-fluorophenyl)ethan-1-ol (CAS 1446417-95-3)
- 3-Bromo-5-iodo-2-methoxypyridin-4-amine (CAS 1227268-98-5)
- 3-Fluoro-1-methylpiperidin-4-amine dihydrochloride (CAS 2306277-16-5)
- 2,8-Dimethylanthra[2,3-b:6,7-b']dithiophene (CAS 1019983-99-3)
- Chloro(phthalocyaninato)iron (CAS 14285-56-4)
- Methyl 3-amino-5-methylhexanoate (CAS 1005188-12-4)
- Semaglutide Impurity 246 (CAS CATO-C4X-2226246)
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