Prednisolone EP Impurity I CAS 13479-38-4
| CAS No. | 13479-38-4 |
| Molecular Formula | C21H28O4 |
| Molecular Weight | 344.44 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Prednisolone EP Impurity I.
Prednisolone EP Impurity I (CAS 13479-38-4) 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 EP Impurity I 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.
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.
Physical & Chemical Properties
| Molecular Formula | C21H28O4 |
| Molecular Weight | 344.44 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 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.) | 1960 |
Related Prednisolone Standards
- Prednisolone EP Impurity J (CAS 1807-14-3)
- Prednisolone impurity 54 (CAS CATO-C4X-173754)
- Prednisolone Acetate EP Impurity D (CAS 20423-99-8)
- 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)
- Lovastatin Impurity 12 (CAS CATO-C4X-168412)
- Fluvoxamine Impurity 54 (CAS CATO-C4X-195154)
- Hydrocortisone Impurity 68 (CAS 3103-16-0)
- Salbutamol Impurity 178 (CAS CATO-C4X-1176178)
- Metaraminol Impurity 106 (CAS CATO-C4X-2252106)
- Eldecalcitol Impurity 27 (CAS CATO-C4X-214027)
- 1,2-diphytanoyl-sn-glycero-3-phospho-(1'-rac-glycerol) sodium salt 474967-73-2 (CAS 474967-73-2)
- 3-Butyl-3-hydroxy-1-methylquinoline-2,4(1H,3H)-dione (CAS 186766-14-3)
- Pyrazolo[1,5-a]pyridin-2-yl-methanol hydrochloride (CAS 1187932-28-0)
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- 5-MEthoxy-imidazo[1,2-a]pyridine-2-carboxaldehyde (CAS 881841-58-3)
- Semaglutide impurity 250 (CAS CATO-C4X-2226250)
Why CATO?
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