| CAS No. | 194039-81-1 |
| Molecular Formula | C7H4F12O2 |
| Molecular Weight | 348.09 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Sevoflurane Impurity 4.
As a process- or degradation-related impurity, Sevoflurane Impurity 4 (CAS 194039-81-1, C7H4F12O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Sevoflurane Impurity 4 (C7H4F12O2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution. 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. 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.
| Molecular Formula | C7H4F12O2 |
| Molecular Weight | 348.09 g/mol |
| Purity | 97%+ |
| Storage | Store at room temperature |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 0.0 |
| CAS Registry Year (est.) | 2012 |
| Halogen Content | F-containing |