Sitagliptin EP Impurity A CAS 823817-55-6
| CAS No. | 823817-55-6 |
| Molecular Formula | C16H15F6N5O |
| Molecular Weight | 407.31 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 407.31 g/mol gives Sitagliptin EP Impurity A distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Sitagliptin EP Impurity A (CAS 823817-55-6) is a certified pharmaceutical impurity reference standard with the molecular formula C16H15F6N5O and a molecular weight of 407.31 g/mol.
Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Sitagliptin EP Impurity A is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 407.31 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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.
As a certified reference material (CRM), Sitagliptin EP Impurity A 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 | C16H15F6N5O |
| Molecular Weight | 407.31 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at room temperature, 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.) | 1986 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 5 |
Related Sitagliptin Standards
- Sitagliptin Impurity 116 (CAS 945261-50-7)
- Sitagliptin Impurity 156 (CAS 945261-49-4)
- Rac Sitagliptin (CAS 823817-56-7)
- Sitagliptin (CAS 486460-32-6)
- Sitagliptin Impurity 10 (CAS 1253056-01-7)
- Sitagliptin Impurity 108 (CAS CATO-C4X-1144108)
- Sitagliptin Impurity 109 (CAS CATO-C4X-1144109)
- Sitagliptin Impurity 137 (CAS CATO-C4X-1144137)
Recommended Standards
- tert-Butyl 4-hydroxy-4-{[4-(tetramethyl-1,3,2-dioxaborolan-2-yl)-1H-pyrazol-1-yl]methyl}piperidine-1-carboxylate (CAS 877399-39-8)
- Ethyl 5-(4-fluorophenyl)-7-(perfluoroethyl)-4,5,6,7-tetrahydropyrazolo[1,5-a]pyrimidine-3-carboxylate (CAS 827594-60-5)
- 8-(5,7-Bis(trifluoromethyl)-1,8-naphthyridin-2-yl)-1,4-dioxa-8-azaspiro[4.5]Decane (CAS 303151-61-3)
- 4-(4-Chlorophenoxy)-2-{[(4-chlorophenyl)methyl]sulfanyl}-6-(methoxymethyl)pyrimidine (CAS 338748-07-5)
- Fluconazole Impurity 44 (CAS 6086-21-1)
- Linagliptin Impurity 4 (CAS 2749405-42-1)
- Mirabegron impurity 101 (CAS CATO-C4X-1032101)
- N-(3-Methyl-4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)phenyl)methanesulfonamide (CAS 1006380-18-2)
- 2,3,4,4a,5,9b-Hexahydro-1H-pyrido[3,2-b]indole (CAS 1530792-46-1)
- 5-Methoxy-2-((2-methylbenzyl)oxy)benzaldehyde (CAS 831237-04-8)
- Dibenzyl (Chloromethyl)phosphonate (CAS 166049-87-2)
- 4-Amino-6-chloro-2-methylpyrimidine-5-carbonitrile (CAS 76574-37-3)
- 3-Fluoro-4-trifluoromethylbenzoic acid (CAS 115754-21-7)
- Peptide Impurity 34 (CAS 21282-09-7)
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