Dolutegravir Impurity 21 CAS CATO-C4X-162021
| CAS No. | CATO-C4X-162021 |
| Molecular Formula | C20H18F2N4O6 |
| Molecular Weight | 448.38 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Dolutegravir Impurity 21 is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Dolutegravir Impurity 21 (CAS CATO-C4X-162021, C20H18F2N4O6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C20H18F2N4O6, Dolutegravir Impurity 21 contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 448.38 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 | C20H18F2N4O6 |
| Molecular Weight | 448.38 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) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 4 |
Related Dolutegravir Standards
- Dolutegravir Impurity 61 (CAS CATO-C4X-162061)
- Dolutegravir Impurity 52 (CAS CATO-C4X-162052)
- Dolutegravir Impurity 55 (CAS CATO-C4X-162055)
- Dolutegravir M3 (CAS 1485692-24-7)
- Dolutegravir Impurity 15 (CAS 2384108-28-3)
- Dolutegravir Impurity 34 (CAS 2227442-13-7)
- Dolutegravir Impurity 35 (CAS 2583719-57-5)
- Dolutegravir Impurity 42 (CAS CATO-C4X-162042)
Recommended Standards
- Orobol 7-O-β-D-glucoside (CAS 20486-33-3)
- Orientin (CAS 28608-75-5)
- Luteollin 5-Glucoside (CAS 20344-46-1)
- Quercitrin (CAS 522-12-3)
- Mabuterol Impurity 10 HCl (CAS CATO-C4X-145410)
- Amorolfine EP Impurity J HCl (CAS CATO-C4X-154210)
- Cefoperazone Impurity 41 (CAS CATO-C4X-114941)
- tert-butyl (3R,4R)-3-azido-4-(cyanomethyl)pyrrolidine-1-carboxylate (CAS 2416992-74-8)
- Benzo-2,1,3-thiadiazole-4-boronic acid (CAS 499769-94-7)
- Sodium Hydrosulfide Hydrate (CAS 207683-19-0)
- Ethyl 5-cyano-2-methoxynicotinate (CAS 1805485-37-3)
- Dichlorotetrakis(pyridine)ruthenium (CAS 16997-43-6)
- tert-Butyl (4-((3-nitroquinolin-4-yl)amino)butyl)carbamate (CAS 210303-93-8)
- Semaglutide Impurity 189 (CAS CATO-C4X-2226189)
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