Sitagliptin EP Impurity C CAS 945261-48-3
| CAS No. | 945261-48-3 |
| Molecular Formula | C16H16F5N5O |
| Molecular Weight | 389.32 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Sitagliptin EP Impurity C is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
CATO supplies Sitagliptin EP Impurity C (CAS 945261-48-3), a pharmacopoeial impurity reference standard (molecular formula C16H16F5N5O, MW 389.32 g/mol) used for the identification and quantification of trace impurities in APIs.
Sitagliptin EP Impurity C (C16H16F5N5O) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. Halogen substitution raises its density and boiling point; 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.
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 EP Impurity C 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 | C16H16F5N5O |
| Molecular Weight | 389.32 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 5 |
Related Sitagliptin Standards
- Sitagliptin Impurity 75 (CAS 1334244-24-4)
- Sitagliptin Impurity 151 (CAS 1334244-32-4)
- Sitagliptin Impurity 152 (CAS CATO-C4X-1144152)
- Sitagliptin EP Impurity B (CAS 486460-31-5)
- Sitagliptin Impurity 99 (CAS 486459-88-5)
- Sitagliptin Impurity 86 (CAS 1246961-45-4)
- Sitagliptin Impurity 105 (CAS CATO-C4X-1144105)
- Sitagliptin Impurity 57 (CAS 1803026-58-5)
Recommended Standards
- Heptachlor epoxide Impurity 4 (CAS 76986-14-6)
- trans-Heptachlor Epoxide Isomer A (CAS 28044-83-9)
- 4-(2-Bromo-5-cyclohexyl-3-hydroxypent-1-en-1-yl)hexahydro-2H-cyclopenta[b]furan-2,5-diol (CAS 60057-00-3)
- cis-Heptachlor Epoxide (CAS 1024-57-3)
- Olanzapine Impurity 42 (CAS 161696-76-0(free base))
- Methylene blue Impurity 17 (CAS CATO-C4X-189617)
- Brimonidine Impurity 31 (CAS CATO-C4X-156631)
- (S)-1-(2-Fluoro-3-(trifluoromethyl)phenyl)ethan-1-amine (CAS 1228570-38-4)
- Methyl 3-((2,4-dichlorophenoxy)methyl)-6-(trifluoromethyl)thieno[3,2-b]pyridine-2-carboxylate (CAS 1400872-29-8)
- 1-phenyl-2-(pyrrolidin-2-yl)ethan-1-ol (CAS 1354959-11-7)
- 1-(5-Bromo-2-methylphenyl)-2,2,2-trifluoroethan-1-one (CAS 1537447-67-8)
- N~1~-Benzyl-N~1~,4-dimethyl-1,2-benzenediamine (CAS 1097786-19-0)
- (4-Benzyltetrahydro-2h-pyran-4-yl)methanamine hydrochloride (CAS 1385696-55-8)
- Angiotensin III Antipeptide (CAS 133605-55-7)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
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- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com