Prednisolone Acetate EP Impurity D CAS 20423-99-8
| CAS No. | 20423-99-8 |
| Molecular Formula | C21H28O4 |
| Molecular Weight | 344.44 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Prednisolone Acetate EP Impurity D is closely related to a flavonoid core, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Prednisolone Acetate EP Impurity D (CAS 20423-99-8) is a certified pharmaceutical impurity reference standard with the molecular formula C21H28O4 and a molecular weight of 344.44 g/mol.
Owing to a flavonoid core, a hydroxyl group, an ether linkage, Prednisolone Acetate EP Impurity D is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 344.44 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 certified reference material (CRM), Prednisolone Acetate EP Impurity D 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 | C21H28O4 |
| Molecular Weight | 344.44 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >90% |
| 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) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1962 |
Related Prednisolone Standards
- Prednisolone EP Impurity J (CAS 1807-14-3)
- Prednisolone impurity 54 (CAS CATO-C4X-173754)
- Prednisolone EP Impurity I (CAS 13479-38-4)
- Prednisolone Impurity 22 (CAS 37927-29-0)
- Prednisolone impurity 57 (CAS 95671-46-8)
- Prednisolone Impurity 52 (CAS 118864-87-2)
- Prednisolone Impurity 28 (CAS CATO-C4X-191928)
- Prednisolone EP Impurity H (CAS 2427-64-7)
Recommended Standards
- Methylprednisolone EP Impurity E (CAS 229019-44-7)
- Fluvoxamine Impurity 54 (CAS CATO-C4X-195154)
- Ruxolitinib impurity 50 (CAS CATO-C4X-205850)
- Lovastatin Impurity 12 (CAS CATO-C4X-168412)
- Baxdrostat Impurity 6 (CAS 1428652-88-3)
- Pimavanserin Impurity 7 (CAS 4734-09-2 (free base))
- Linezolid Impurity 100 (CAS CATO-C4X-1073100)
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- 4,7-Dichloro-2-isopropylquinazoline (CAS 1185248-75-2)
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- Semaglutide Impurity 176 (CAS CATO-C4X-2226176)
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