Mycophenolate Mofetil EP Impurity E CAS 31858-66-9
| CAS No. | 31858-66-9 |
| Molecular Formula | C18H22O6 |
| Molecular Weight | 334.36 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Mycophenolate Mofetil EP Impurity E (CAS 31858-66-9, C18H22O6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Mycophenolate Mofetil EP Impurity E (C18H22O6) 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 334.36 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).
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 | C18H22O6 |
| Molecular Weight | 334.36 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | 97%+ |
| 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.) | 1966 |
Related Mycophenolate Standards
- Mycophenolate Mofetil Impurity 17 (CAS 26644-06-4)
- Mycophenolate Impurity 25 (CAS CATO-C4X-151525)
- Mycophenolate Impurity 26 (CAS CATO-C4X-151526)
- Mycophenolate Impurity 22 (CAS CATO-C4X-151522)
- Mycophenolate Impurity 24 (CAS CATO-C4X-151524)
- Mycophenolate Mofetil Impurity 14 (CAS 33431-38-8)
- Mycophenolate Mofetil Impurity 15 (CAS 24243-38-7)
- Mycophenolate Mofetil EP Impurity H (CAS 79081-87-1)
Recommended Standards
- Flurbiprofen Axetil-13C-d3 (CAS 91503-79-6 (non-labelled))
- Mycophenolic Acid Impurity 11 (CAS 38877-93-9)
- CAS 53170-92-6 (CAS 53170-92-6)
- Phloroglucinol impurity 46 (CAS CATO-C4X-221746)
- Azilsartan Impurity 39 (CAS CATO-C4X-109639)
- Atracurium Impurity 75 (CAS CATO-C4X-185075)
- Dolutegravir Impurity 4 (CAS 1357289-37-2)
- 5-Methoxy-2-(4-methoxyphenyl)-2H-indazole (CAS 120455-06-3)
- 4-Cyclopropyl-3-(hydroxymethyl)benzaldehyde (CAS 2830620-94-3)
- 2-(Chloromethyl)benzofuro[3,2-d]pyrimidin-4(3H)-one (CAS 80550-76-1)
- Ezetimibe diacetate (CAS 163380-20-9)
- 3-(Prop-2-yn-1-yl)tetrahydrofuran-2-ol (CAS 1321861-62-4)
- 4-Chloro-3-hydroxybenzoyl chloride (CAS 888731-75-7)
- Antiarrhythmic peptide (cattle atrium) (CAS 81771-37-1)
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