Budesonide Impurity 61 CAS 131711-17-6
| CAS No. | 131711-17-6 |
| Molecular Formula | C23H27BrO5 |
| Molecular Weight | 463.36 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Owing to a flavonoid core, a hydroxyl group, an ether linkage, bromine substitution, Budesonide Impurity 61 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 463.36 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.
As a process- or degradation-related impurity, Budesonide Impurity 61 (CAS 131711-17-6, C23H27BrO5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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 | C23H27BrO5 |
| Molecular Weight | 463.36 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| 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.) | 1994 |
| Halogen Content | Br-containing |
Related Budesonide Standards
- Budesonide impurity 46 (CAS 1831164-04-5)
- Budesonide Impurity 38 (CAS CATO-C4X-138938)
- Budesonide EP Impurity K (Mixture of Epimer) (CAS 51333-05-2)
- Budesonide Impurity 66 (CAS CATO-C4X-138966)
- Budesonide Impurity 76 (CAS CATO-C4X-138976)
- Budesonide EP Impurity I (CAS 113930-13-5)
- Budesonide 17,21-Diacetyloxy Impurity (CAS 17652-24-3)
- Budesonide Impurity 22(Mixture of Diastereomers) (CAS CATO-C4X-138922)
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