| CAS No. | 2136287-88-0 |
| Molecular Formula | C30H31F2N3O4S |
| Molecular Weight | 567.65 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The occurrence of Baloxavir Impurity 12 is closely related to a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Baloxavir Impurity 12 (CAS 2136287-88-0) is a certified pharmaceutical impurity reference standard with the molecular formula C30H31F2N3O4S and a molecular weight of 567.65 g/mol.
Baloxavir Impurity 12 (C30H31F2N3O4S) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine 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. 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 | C30H31F2N3O4S |
| Molecular Weight | 567.65 g/mol |
| 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) | 16.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1997 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
| Sulfur Atoms | 1 |