Sucralose EP Impurity B CAS 40631-75-2
| CAS No. | 40631-75-2 |
| Molecular Formula | C12H19Cl3O8 |
| Molecular Weight | 397.63 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
CATO supplies Sucralose EP Impurity B (CAS 40631-75-2), a pharmacopoeial impurity reference standard (molecular formula C12H19Cl3O8, MW 397.63 g/mol) used for the identification and quantification of trace impurities in APIs.
Sucralose EP Impurity B (C12H19Cl3O8) contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine 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.
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 | C12H19Cl3O8 |
| Molecular Weight | 397.63 g/mol |
| Purity | 97%+ |
| 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.) | 1968 |
| Halogen Content | Cl-containing |
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