Sitagliptin Impurity 11 CAS 1379666-94-0
| CAS No. | 1379666-94-0 |
| Molecular Formula | C18H17F6N5O2 |
| Molecular Weight | 449.35 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Sitagliptin Impurity 11 (CAS 1379666-94-0, C18H17F6N5O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Sitagliptin Impurity 11 (C18H17F6N5O2) is characterized by a steroid core, 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 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.
Physical & Chemical Properties
| Molecular Formula | C18H17F6N5O2 |
| Molecular Weight | 449.35 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1991 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 5 |
Related Sitagliptin Standards
- Sitagliptin Impurity 132 (CAS CATO-C4X-1144132)
- Sitagliptin Impurity 74 (CAS 3056-18-6)
- Sitagliptin Impurity 129 (CAS CATO-C4X-1144129)
- Sitagliptin impurity 114 (CAS CATO-C4X-1144114)
- Sitagliptin Impurity 133 (CAS CATO-C4X-1144133)
- Sitagliptin Impurity 130 (CAS CATO-C4X-1144130)
- Sitagliptin impurity 112 (CAS CATO-C4X-1144112)
- Sitagliptin impurity 29 (CAS 2088771-61-1)
Recommended Standards
- 3-{4-[(3,5-dichlorophenyl)sulfonyl]piperazino}-6-phenylpyridazine 478077-50-8 KS-00003DJ6 (CAS 478077-50-8)
- Ethyl 6-bromo-5-hydroxy-1-methyl-2-((((phenylthio)methyl)amino)methyl)-1H-indole-3-carboxylate (CAS 1704066-66-9)
- Tert-butyl 6-(benzyloxy)-3-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)-1H-indole-1-carboxylate (CAS 2304633-94-9)
- 2-(4-((4-Bromophenyl)sulfonyl)-1,4-diazepan-1-yl)-4,6-dimethylnicotinonitrile (CAS 478256-86-9)
- Palbociclib Impurity 141 (CAS CATO-C4X-1125141)
- Coclaurine Impurity 115 (CAS CATO-C4X-275115)
- Abemaciclib Impurity 30 DiHCl (CAS 2124229-65-6 (free base))
- 3-((1H-pyrazol-1-yl)methyl)-4-ethoxybenzaldehyde (CAS 1015844-31-1)
- 5-Acetyl-2-(diethylamino)-6-methylnicotinonitrile (CAS 303146-98-7)
- Desacetyl Actarit-d4 (CAS 1185174-46-2)
- 4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)-1-(trideuteriomethyl)pyrazole (CAS 1022151-50-3)
- Ethyl 3-(4-methoxyphenyl)but-2-enoate (CAS 7706-82-3)
- (2S,3R,4S,5S,6R)-2-(((2R,3S,4R,5R,6S)-6-((6-chloro-1H-indol-3-yl)oxy)-4,5-dihydroxy-2-(hydroxymethyl)tetrahydro-2H-pyran-3-yl)oxy)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (CAS 425427-87-8)
- Semaglutide impurity 65 (CAS CATO-C4X-222665)
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