Sitagliptin Impurity 57 HCl CAS 269396-58-9
| CAS No. | 269396-58-9 |
| Molecular Formula | C10H11F2NO2 |
| Molecular Weight | N/A |
| Category | Pharmaceutical Standards / API Standards |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Sitagliptin Impurity 57 HCl.
Sitagliptin Impurity 57 HCl (CAS 269396-58-9), molecular formula C10H11F2NO2HCl and molecular weight 251.66 g/mol, is a CATO reference standard with documented purity and traceability.
Sitagliptin Impurity 57 HCl (C10H11F2NO2HCl) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; 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 is suitable for quantitative analysis on major chromatographic platforms including HPLC, GC, LC-MS/MS, and GC-MS, serving as an external calibration standard or a system suitability test reference material.
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 | C10H11F2NO2 HCl |
| Molecular Weight | 251.66 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| 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) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2025 |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 1 |
Related Sitagliptin Standards
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- 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
- 2-Thiouracil (CAS 141-90-2)
- (1-(2,5-Dichlorophenyl)cyclobutyl)methanamine (CAS 1935531-06-8)
- (Z)-6-(2-Formyl-5-oxopyrrolidin-1-yl)hex-4-enoic acid (CAS 62401-64-3)
- 3-(3-Nitrophenoxy)propan-1-ol (CAS 63082-35-9)
- 2-Ethyl-2,6-diazaspiro[3.3]Heptane (CAS 1824315-23-2)
- 6-Bromo-2-[2-(5-methylfuran-2-yl)ethenyl]quinoline-4-carboxylic acid (CAS 926273-86-1)
- 2-Acetylamino-5-thiazolecarboxylic acid methyl ester (CAS 1174534-36-1)
- N-(7-hydroxy-2-oxo-2H-chromen-3-yl)-4-methylbenzamide (CAS 339009-37-9)
- 2,2,2-Trichloro-1-(5-chloro-1H-indol-3-yl)ethanone (CAS 1823480-57-4)
- Endo-38a-Pro-Exenatide trifluoroacetate salt (CAS 1678416-95-9)
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