Sitagliptin Impurity 37 CAS 486459-98-7
| CAS No. | 486459-98-7 |
| Molecular Formula | C15H19F2NO4 |
| Molecular Weight | 315.31 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Sitagliptin Impurity 37 (CAS 486459-98-7, C15H19F2NO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Sitagliptin Impurity 37 (C15H19F2NO4) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Physical & Chemical Properties
| Molecular Formula | C15H19F2NO4 |
| Molecular Weight | 315.31 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2025 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Sitagliptin Standards
- Sitagliptin Impurity 3 (CAS 1824443-71-1)
- Sitagliptin Impurity 36 (CAS 851307-12-5)
- Sitagliptin Impurity 38 (CAS 269396-59-0)
- Sitagliptin Impurity 52 (CAS 764667-64-3)
- Sitagliptin Impurity 77 (CAS 1152439-73-0)
- Sitagliptin Impurity 7 (CAS 767352-30-7)
- Sitagliptin Impurity 56 (CAS 1582-05-4)
- Sitagliptin Impurity 134 (CAS CATO-C4X-1144134)
Recommended Standards
- N-Benzyl-2-(trifluoromethyl)benzene-1-sulfonamide (CAS 612042-73-6)
- 2-(3,6-Dicyclopropyl-4-(methoxycarbonyl)-1H-pyrazolo[3,4-b]pyridin-1-yl)acetic acid (CAS 1018051-85-8)
- N-[(Thiophen-2-yl)methyl]-4-(2,2,2-trifluoroethoxy)benzamide (CAS 866153-62-0)
- N-(2-(4-Acetamidobenzamido)ethyl)furan-2-carboxamide (CAS 1021136-99-1)
- Tofacitinib Impurity 168 (CAS CATO-C4X-1079168)
- Valproate Impurity 70 (CAS 66546-90-5)
- Lumefantrine Impurity 9 (CAS 7061-81-6)
- Cholic Acid Impurity 49 (CAS 691519-36-4)
- 3-Chloro-4-fluoro-4-thiomorpholinomethyl benzophenone (CAS 898782-87-1)
- N'-(4-Bromobenzylidene)-2-(4-nitrophenyl)acetohydrazide (CAS 328556-36-1)
- 3-Iodo-1-methyl-1H-pyrazolo[3,4-d]pyrimidine (CAS 1219636-66-4)
- (S)-5-bromo-4-chloro-2,3-dihydro-1H-inden-1-amine (CAS 1272721-19-3)
- trans-4-Dimethylaminocinnamonitrile (CAS 32444-63-6)
- Uremic Pentapeptide (CAS 71494-20-7)
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