Drospirenone EP Impurity H CAS 932388-89-1
| CAS No. | 932388-89-1 |
| Molecular Formula | C24H31ClO3 |
| Molecular Weight | 402.95 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, Drospirenone EP Impurity H (CAS 932388-89-1, C24H31ClO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C24H31ClO3, Drospirenone EP Impurity H contains a steroid core, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 402.95 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).
As a certified reference material (CRM), Drospirenone EP Impurity H meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C24H31ClO3 |
| Molecular Weight | 402.95 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| 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.) | 1987 |
| Halogen Content | Cl-containing |
Related Drospirenone Standards
- Drospirenone EP Impurity G (CAS 932388-90-4)
- Drospirenone Impurity 12 (CAS 82543-18-8)
- Drospirenone 3,5,5-Triol (CAS 1079392-41-8)
- Drospirenone Impurity 13(Mixture of Diastereomers) (CAS CATO-C4X-162413)
- Drospirenone 5,5-Diol (CAS 863329-70-8)
- Drospirenone Impurity 17 (CAS 82543-17-7)
- Drospirenone AcidDISCONTINUED, offer stable alternates (CAS 776251-13-9)
- Drospirenone EP Impurity B (CAS CATO-C4X-16242)
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- N-(2,5-dimethylphenyl)-2-((2-methoxyethyl)amino)acetamide hydrochloride (CAS 1572317-62-4)
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