Sucralose Impurity 4 CAS CATO-C4X-28294
| CAS No. | CATO-C4X-28294 |
| Molecular Formula | C12H19F3O8 |
| Molecular Weight | 348.27 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 348.27 g/mol gives Sucralose Impurity 4 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
As a process- or degradation-related impurity, Sucralose Impurity 4 (CAS CATO-C4X-28294, C12H19F3O8) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Sucralose Impurity 4 (C12H19F3O8) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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 | C12H19F3O8 |
| Molecular Weight | 348.27 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 |
| Halogen Content | F-containing |
Related Sucralose Standards
Recommended Standards
- 2-(1H-Indol-3-yl)-2-oxo-N-[3-(trifluoromethoxy)phenyl]acetamide (CAS 1023559-26-3)
- N-(4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)phenyl)thiomorpholine-4-carboxamide (CAS 874298-05-2)
- 4-((3-(4-(Trifluoromethyl)phenyl)-1,2,4-oxadiazol-5-yl)methoxy)benzaldehyde (CAS 1042852-63-0)
- N-(3-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)phenyl)thiomorpholine-4-carboxamide (CAS 874301-68-5)
- Formoterol Impurity 87 (CAS CATO-C4X-152587)
- Propranolol Impurity 19 (CAS 62618-09-1)
- Azelastine impurity 62 (CAS CATO-C4X-139662)
- Methyl 5,6-dimethyl-3-phenylpicolinate (CAS 57768-13-5)
- 1,8-Diazido-3,5-dioxaoctane (CAS 59559-06-7)
- Ethyl 2-(4-(2-chlorophenyl)-3-methyl-5-oxo-4,5-dihydro-1H-1,2,4-triazol-1-yl)acetate (CAS 861205-99-4)
- 4-{[3-(1-methoxycyclopentyl)-1,2,4-oxadiazol-5-yl]methyl}piperidine (CAS 1918078-41-7)
- (S)-5-(tert-butoxycarbonyl)-5-azaspiro[2.4]Heptane-4-carboxylic acid (CAS 209269-08-9)
- tert-butyl 4-fluoro-3-hydroxybenzoate (CAS 847943-90-2)
- Tirzepatide Impurity 33 (CAS CATO-C4X-324033)
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