| CAS No. | 167997-11-7 |
| Molecular Formula | C21H28O5 |
| Molecular Weight | 360.44 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
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, 17-Hydroxy-Methylprednisolone Impurity E Derivative (CAS 167997-11-7, C21H28O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, 17-Hydroxy-Methylprednisolone Impurity E Derivative (C21H28O5) contains a flavonoid core, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 360.44 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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.
| Molecular Formula | C21H28O5 |
| Molecular Weight | 360.44 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 methanol, acetonitrile, DMSO, water (slightly soluble) |
| 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.) | 2004 |