Clobetasone Butyrate EP Impurity A CAS 54063-32-0
| CAS No. | 54063-32-0 |
| Molecular Formula | C22H26ClFO4 |
| Molecular Weight | 408.89 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.
As a process- or degradation-related impurity, Clobetasone Butyrate EP Impurity A (CAS 54063-32-0, C22H26ClFO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C22H26ClFO4, Clobetasone Butyrate EP Impurity A contains a flavonoid core, a hydroxyl group, an ether linkage, fluorine/chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 408.89 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C22H26ClFO4 |
| Molecular Weight | 408.89 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| 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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1972 |
| Halogen Content | F/Cl-containing |
Related Clobetasone Standards
- Clobetasone Butyrate EP Impurity H (CAS 25122-56-9)
- Clobetasone Butyrate EP Impurity I (CAS 639817-47-3)
- Clobetasone Butyrate EP Impurity F (CAS 25120-98-3)
- Clobetasone 17-Butyrate (CAS 25122-57-0)
- Clobetasone butyrate EP Impurity E (CAS 639817-48-4)
- Clobetasone butyrate EP Impurity C (CAS 639817-49-5)
- Clobetasone butyrate EP Impurity G (CAS CATO-C4X-35394)
- Clobetasone Butyrate Impurity 7 (CAS CATO-C4X-35397)
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