| CAS No. | 475491-24-8 |
| Molecular Formula | C12H19F3O8 |
| Molecular Weight | 348.27 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Sucralose Impurity 2 (CAS 475491-24-8) is a certified pharmaceutical impurity reference standard with the molecular formula C12H19F3O8 and a molecular weight of 348.27 g/mol.
Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, Sucralose Impurity 2 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 348.27 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
As a certified reference material (CRM), Sucralose Impurity 2 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
| Molecular Formula | C12H19F3O8 |
| Molecular Weight | 348.27 g/mol |
| Purity | >90% |
| Storage | Store in a cool place (≤25°C), keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 2.0 |
| CAS Registry Year (est.) | 2025 |
| Halogen Content | F-containing |