Lifitegrast Impurity 65 CAS 2637374-15-1
| CAS No. | 2637374-15-1 |
| Molecular Formula | C28H30N2O4 |
| Molecular Weight | 458.55 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The molecular framework of Lifitegrast Impurity 65 (C28H30N2O4) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. 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 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).
As a process- or degradation-related impurity, Lifitegrast Impurity 65 (CAS 2637374-15-1, C28H30N2O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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.
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 | C28H30N2O4 |
| Molecular Weight | 458.55 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | ≥95% |
| 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 |
| Degree of Unsaturation (DBE) | 15.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2001 |
| Nitrogen Atoms | 2 |
Related Lifitegrast Standards
- Lifitegrast Impurity 100 (CAS CATO-C4X-2409100)
- Lifitegrast Impurity 44 (CAS CATO-C4X-240944)
- Lifitegrast Impurity 46 (CAS CATO-C4X-240946)
- Lifitegrast Impurity 166 (CAS CATO-C4X-2409166)
- Lifitegrast Impurity 13 (CAS CATO-C4X-240913)
- Lifitegrast Impurity 135 (CAS CATO-C4X-2409135)
- Lifitegrast Impurity 69 (CAS CATO-C4X-240969)
- Lifitegrast impurity 92 (CAS CATO-C4X-240992)
Recommended Standards
- Pemafibrate Impurity 90 (CAS CATO-C4X-290390)
- Relebactam Impurity 16 (CAS CATO-C4X-214416)
- (3R,4S,5R)-3-(acetyloxy)-4-(benzyloxy)-5-[(benzyloxy)methyl]-5-(fluoromethyl)oxolan-2-yl acetate (CAS 196604-56-5)
- Ramipril Impurity 19 (CAS CATO-C4X-174419)
- Lifitegrast Impurity 145 (CAS CATO-C4X-2409145)
- Mirogabalin Impurity 147 (CAS CATO-C4X-2924147)
- Arbidol impurity 44 (CAS CATO-C4X-112944)
- 6-(((1-Methyl-1H-imidazol-2-yl)thio)methyl)-4-oxo-4H-pyran-3-yl thiophene-2-carboxylate (CAS 896311-46-9)
- N-(4-acetylphenyl)-3-methylbenzamide (CAS 302813-90-7)
- 4-Chloro-5-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)-2H-indazole (CAS 2818961-77-0)
- 3-(2,5-Dimethoxyphenyl)-N-phenyl-2-(2H-1,2,3,4-tetrazol-5-yl)propanamide (CAS 483995-12-6)
- 1-(4-Nitrobenzyl)pyridin-1-ium chloride (CAS 4329-72-0)
- 1-(4-Methylquinolin-1(4H)-yl)ethanone (CAS 634891-63-7)
- Semaglutide Impurity 161 (x TFA Salt) (CAS CATO-C4X-2226161)
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