Hydrocortisone EP Impurity D CAS 53-35-0
| CAS No. | 53-35-0 |
| Molecular Formula | C21H30O6 |
| Molecular Weight | 378.46 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, Hydrocortisone EP Impurity D is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 378.46 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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).
Hydrocortisone EP Impurity D (CAS 53-35-0) is a certified pharmaceutical impurity reference standard with the molecular formula C21H30O6 and a molecular weight of 378.46 g/mol.
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), Hydrocortisone 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 | C21H30O6 |
| Molecular Weight | 378.46 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >90% |
| 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |
Related Hydrocortisone Standards
- Hydrocortisone EP Impurity O (CAS 154032-37-8)
- Hydrocortisone Impurity 21 (CAS 68473-77-8)
- Hydrocortisone EP Impurity H (CAS CATO-C4X-14018)
- Hydrocortisone EP Impurity I (CAS 103795-84-2)
- Hydrocortisone 21-Carboxylic Acid (CAS 57172-48-2)
- Hydrocortisone Impurity 65 (CAS CATO-C4X-140165)
- Hydrocortisone Impurity 71 (CAS 37413-94-8)
- Hydrocortisone EP Impurity E (CAS 7753-60-8)
Recommended Standards
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- Neotame (CAS 165450-17-9)
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