Drospirenone EP Impurity B CAS CATO-C4X-16242
| CAS No. | CATO-C4X-16242 |
| Molecular Formula | C24H32O4 |
| Molecular Weight | 384.51 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, Drospirenone EP Impurity B (CAS CATO-C4X-16242, C24H32O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Drospirenone EP Impurity B (C24H32O4) contains a flavonoid core, a hydroxyl group, an ether linkage. 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 presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 | C24H32O4 |
| Molecular Weight | 384.51 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, 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 |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
Related Drospirenone Standards
- Drospirenone AcidDISCONTINUED, offer stable alternates (CAS 776251-13-9)
- Drospirenone 5β-Hydroxy Impurity (CAS 197721-70-3)
- Drospirenone 5,5-Diol (CAS 863329-70-8)
- Drospirenone Impurity 17 (CAS 82543-17-7)
- Drospirenone 3,5,5-Triol (CAS 1079392-41-8)
- Drospirenone Impurity 13(Mixture of Diastereomers) (CAS CATO-C4X-162413)
- Drospirenone Impurity 12 (CAS 82543-18-8)
- Drospirenone-20,20,21,21-d4 (CAS 2376035-94-6)
Recommended Standards
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- Ritonavir Impurity 34 (CAS CATO-C4X-175134)
- Cefminox Impurity 4 (CAS CATO-C4X-19264)
- Pentoxifylline Impurity 30 (CAS CATO-C4X-172830)
- Phentolamine Impurity 20 (CAS CATO-C4X-224720)
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