Prednisolone EP Impurity H CAS 2427-64-7
| CAS No. | 2427-64-7 |
| Molecular Formula | C21H26O5 |
| Molecular Weight | 358.43 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, Prednisolone EP Impurity H (CAS 2427-64-7, C21H26O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Prednisolone EP Impurity H (C21H26O5) is characterized by a flavonoid core, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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).
As a certified reference material (CRM), Prednisolone 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 | C21H26O5 |
| Molecular Weight | 358.43 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 methanol, acetonitrile, DMSO, water (slightly soluble) |
| 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 |
| CAS Registry Year (est.) | 1957 |
Related Prednisolone Standards
- Prednisolone Impurity 37 (CAS 307518-72-5)
- Prednisolone Impurity 43 (CAS 905-52-2)
- Prednisolone EP Impurity F (CAS 600-90-8)
- Prednisolone impurity 65 (CAS 20380-15-8)
- Prednisolone Impurity 44 (CAS 7055-53-0)
- Prednisolone 20alpha-Hydroxy Impurity (CAS 15847-24-2)
- Prednisolone EP Impurity G (CAS 2299-46-9)
- Prednisolone impurity 55 (CAS CATO-C4X-173755)
Recommended Standards
- Prednisone Impurity 7 (CAS CATO-C4X-16947)
- Ticarcillin EP Impurity E (CAS CATO-C4X-17635)
- Formoterol Impurity 89 (CAS CATO-C4X-152589)
- Epinastine Impurity 23 (CAS 439288-43-4)
- Abiraterone Impurity 38 (CAS CATO-C4X-107038)
- Norepinephrine impurity 150 (CAS CATO-C4X-1514150)
- Cefaclor Impurity 35 (CAS CATO-C4X-127035)
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