Sitagliptin Impurity 35 CAS 218609-00-1
| CAS No. | 218609-00-1 |
| Molecular Formula | C15H20FNO4 |
| Molecular Weight | 297.32 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Sitagliptin Impurity 35 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.
As a process- or degradation-related impurity, Sitagliptin Impurity 35 (CAS 218609-00-1, C15H20FNO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C15H20FNO4, Sitagliptin Impurity 35 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 297.32 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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.
Physical & Chemical Properties
| Molecular Formula | C15H20FNO4 |
| Molecular Weight | 297.32 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation |
| 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.) | 2019 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Sitagliptin Standards
- Sitagliptin Impurity 26 (CAS 218609-00-8)
- Sitagliptin related compound 1 (CAS 331763-66-7)
- Sitagliptin Impurity 34 (CAS 218608-98-1)
- Sitagliptin Impurity 135 (CAS 1360872-54-3)
- Sitagliptin Impurity 70 (CAS CATO-C4X-114470)
- Sitagliptin Impurity 71 (CAS CATO-C4X-114471)
- Sitagliptin Impurity 82 (CAS 2248445-00-1)
- Sitagliptin Impurity 160 (CAS CATO-C4X-1144160)
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