Sitagliptin Impurity 115 CAS CATO-C4X-1144115
| CAS No. | CATO-C4X-1144115 |
| Molecular Formula | C22H24F6N4O2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
Sitagliptin Impurity 115 (CAS CATO-C4X-1144115) is a certified pharmaceutical impurity reference standard with the molecular formula C22H24F6N4O2HCl and a molecular weight of 526.91 g/mol.
Sitagliptin Impurity 115 (C22H24F6N4O2HCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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).
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.
Physical & Chemical Properties
| Molecular Formula | C22H24F6N4O2 HCl |
| Molecular Weight | 526.91 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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 4 |
Related Sitagliptin Standards
- Sitagliptin Impurity 17 (CAS 1036273-20-7)
- Sitagliptin Impurity 966 (CAS 1151240-88-8)
- Sitagliptin Impurity 14 (CAS 1151240-91-3)
- Sitagliptin Impurity 12 HCl (CAS 1151240-91-3（free base）)
- Sitagliptin Impurity 77 (CAS 1152439-73-0)
- Sitagliptin Impurity 97 (CAS 1169707-29-2)
- Sitagliptin Tablets EP Impurity FP-E HCl (CAS 1204818-19-8)
- Sitagliptin Impurity 15 (CAS 1217809-78-3)
Recommended Standards
- Minocycline EP Impurity G DiTFA salt (CAS 601455-95-2(free base))
- Cloprostenol Impurity 4 (CAS 23518-25-4)
- Ribavirin impurity 57 (CAS CATO-C4X-141357)
- Ilaprazole Impurity 107 (CAS CATO-C4X-1130107)
- Methyl 4-bromo-5-chloro-3-methyl-1H-indole-2-carboxylate (CAS 2413725-84-3)
- 1-[(3,4-Dichlorobenzyl)sulfonyl]piperidine-3-carboxylic acid (CAS 1858242-24-6)
- 2-(4-Nitrophenyl)-2H-1,2,3-triazole (CAS 18922-72-0)
- 6-cyclopropyl-1,3-dimethyl-1H-pyrazolo[3,4-b]pyridine-4-carboxylic acid (CAS 886503-63-5)
- 1,1,7-Trimethyl-2,3-dihydro-1H-inden-4-amine (CAS 100161-87-3)
- Heptapeptide-6 (CAS CATO-CPTD788823)
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