Sitagliptin Impurity 28 CAS 486460-00-8
| CAS No. | 486460-00-8 |
| Molecular Formula | C15H18F3NO4 |
| Molecular Weight | 333.30 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Sitagliptin Impurity 28 (CAS 486460-00-8, C15H18F3NO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Sitagliptin Impurity 28 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 333.30 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
CATO manufactures Sitagliptin Impurity 28 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
Physical & Chemical Properties
| Molecular Formula | C15H18F3NO4 |
| Molecular Weight | 333.30 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| 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 124 (CAS CATO-C4X-1144124)
- Sitagliptin Impurity 18 (CAS 922178-94-7)
- Sitagliptin Impurity 65 (CAS 1620129-74-9)
- Sitagliptin Impurity 56 (CAS 1582-05-4)
- Sitagliptin Impurity 7 (CAS 767352-30-7)
- Sitagliptin Impurity 26 (CAS 1402569-71-4)
- Sitagliptin Impurity 52 (CAS 764667-64-3)
- Sitagliptin Impurity 77 (CAS 1152439-73-0)
Recommended Standards
- Regadenoson Impurity 5 (CAS 1627202-38-3)
- Z-L-valine trifluoroethyl ester (CAS 203640-52-2)
- Flurtamone (CAS 96525-23-4)
- UBP 302 (CAS 745055-91-8)
- Pentoxifylline Impurity 18 (CAS 1185878-98-1)
- Bisoprolol EP Impurity G (CAS 1215342-36-1)
- Terbutaline impurity 130 (CAS CATO-C4X-1183130)
- 4-Fluoro-6-(trifluoromethyl)nicotinonitrile (CAS 1805462-16-1)
- 1-(Dimethylcarbamoyl)piperidine-2-carboxylic Acid (CAS 1249531-45-0)
- Potassium 4-iodophenyltrifluoroborate (CAS 912350-00-6)
- Vonoprazan Impurity 210 (CAS CATO-C4X-1020210)
- N-(3-Fluorobenzyl)-1-(pyrrolidin-2-yl)methanamine hydrochloride (CAS 1261235-05-5)
- 2-Bromo-3-cyclopropoxy-6-isopropylpyridine (CAS 1243396-03-3)
- D-Ile27-Tirzepatide (CAS CATO-CPTD788907)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com