Methylprednisolone EP Impurity E CAS 229019-44-7
| CAS No. | 229019-44-7 |
| Molecular Formula | C21H28O4 |
| Molecular Weight | 344.44 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Methylprednisolone EP Impurity E 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.
As a process- or degradation-related impurity, Methylprednisolone EP Impurity E (CAS 229019-44-7, C21H28O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a flavonoid core, a hydroxyl group, an ether linkage, Methylprednisolone EP Impurity E 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.
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.) | 2022 |
Related Methylprednisolone Standards
- Methylprednisolone EP Impurity D (CAS 1338549-02-2)
- Methylprednisolone EP Impurity G (CAS 93269-35-3)
- Methylprednisolone EP Impurity D(E-Isomer) (CAS CATO-C4X-19194)
- Methylprednisolone Impurity 79 (CAS CATO-C4X-191979)
- Methylprednisolone impurity 6 (CAS CATO-C4X-191986)
- Methylprednisolone Acetate EP Impurity I (CAS 6870-94-6)
- Methylprednisolone Impurity 57 (CAS 1048031-80-6)
- Methylprednisolone Impurity 81 (CAS 82332-00-1)
Recommended Standards
- Prednisolone Acetate EP Impurity D (CAS 20423-99-8)
- Fluvoxamine Impurity 54 (CAS CATO-C4X-195154)
- Prednisolone EP Impurity I (CAS 13479-38-4)
- Ruxolitinib impurity 50 (CAS CATO-C4X-205850)
- Vinpocetine Impurity 40 (CAS CATO-C4X-184340)
- Vitamin impurity 53 (CAS 286475-07-8)
- All-rac-alfa-Tocopheryl Acetate EP Impurity D (Mixture of Isomers) (CAS 2734344-00-2)
- 8-Methylnonyl nonanoate (CAS 109-32-0)
- (S)-1-(2-(Tris(4-methoxyphenyl)methoxy)ethyl)piperidine-3-carboxylic acid (CAS 157604-55-2)
- 6,8-Dichloro-4-hydroxy-2-methylquinoline-3-carboxylic acid (CAS 92146-40-2)
- 4-chloro-1-N-(cyclohexylmethyl)benzene-1,2-diamine (CAS 1096873-04-9)
- 2,2-Difluoro-1-(4-fluorophenyl)ethan-1-ol (CAS 2546-44-3)
- 3-Cyclopropoxy-4-(trifluoromethyl)pyridine (CAS 1243323-04-7)
- D-[Ser]8-Semaglutide (CAS CATO-CPTD788632)
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