Fingolimod impurity 31 CAS CATO-C4X-164631
| CAS No. | CATO-C4X-164631 |
| Molecular Formula | C25H36N2O7 |
| Molecular Weight | 476.56 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
Fingolimod impurity 31 (CAS CATO-C4X-164631) is a certified pharmaceutical impurity reference standard with the molecular formula C25H36N2O7 and a molecular weight of 476.56 g/mol.
Structurally, Fingolimod impurity 31 (C25H36N2O7) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 476.56 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.
Physical & Chemical Properties
| Molecular Formula | C25H36N2O7 |
| Molecular Weight | 476.56 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 2 |
Related Fingolimod Standards
- Fingolimod impurity 26 (CAS 268557-49-9)
- Fingolimod EP Impurity H (CAS 162358-09-0)
- Fingolimod Impurity 13 (CAS 162358-08-9)
- Fingolimod impurity 25 (CAS CATO-C4X-164625)
- Fingolimod EP Impurity E (CAS 851039-25-3)
- Fingolimod EP Impurity F (CAS CATO-C4X-164632)
- Fingolimod Palmitate Amide (CAS 1242271-26-6)
- (R)-Fingolimod O-Phosphate (CAS 402616-23-3)
Recommended Standards
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- Methylprednisolone Hydrogen Succinate EP Impurity D (CAS 119657-85-1)
- Tizanidine EP Impurity C (CAS 1147548-83-1)
- Telmisartan Impurity 50 (CAS 612-28-2)
- Aripiprazole Impurity 42 (CAS CATO-C4X-100842)
- 2-Amino-6,7-dihydrothiazolo[5,4-c]pyridin-4(5H)-one (CAS 26493-11-8)
- 2-Chloro-N-(4-phenoxyphenyl)acetamide (CAS 36160-84-6)
- 2-Hydrazinyl-3-methylquinolin-4(3H)-one (CAS 380665-96-3)
- 3-(3-Chlorophenyl)-3-(1H-pyrrol-1-yl)propanoic acid (CAS 866019-40-1)
- 6,7-Dihydro-5H-cyclopenta[b]pyridine-2-carboxylic acid (CAS 1140239-83-3)
- 877142-62-6 6-Methyl-2H-thieno[2,3-d][1,3]oxazine-2,4(1H)-dione MFCD14281985 (CAS 877142-62-6)
- Insulin Degludec Impurity 17 (CAS CATO-C4X-215717)
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