Prasugrel EP Impurity E CAS 1056459-37-0
| CAS No. | 1056459-37-0 |
| Molecular Formula | C20H21ClFNO3S |
| Molecular Weight | 409.90 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Prasugrel EP Impurity E (CAS 1056459-37-0, C20H21ClFNO3S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Prasugrel EP Impurity E (C20H21ClFNO3S) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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.
Physical & Chemical Properties
| Molecular Formula | C20H21ClFNO3S |
| Molecular Weight | 409.90 g/mol |
| Purity | >90% |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1988 |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 1 |
| Sulfur Atoms | 1 |
Related Prasugrel Standards
- Prasugrel EP Impurity E Maleate Salt (CAS 1373350-61-8)
- Prasugrel Impurity 20 (CAS 109904-26-9)
- Prasugrel Impurity 17 (CAS 109904-25-8)
- Prasugrel D4 (CAS 1189919-49-0)
- Prasugrel (CAS 150322-43-3)
- Prasugrel EP Impurity B (CAS 1391194-39-0)
- Prasugrel EP Impurity C (CAS 1391194-50-5)
- Prasugrel Impurity 21 (CAS 1618107-95-1)
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