Fingolimod EP Impurity G TFA CAS CATO-C4X-164619
| CAS No. | CATO-C4X-164619 |
| Molecular Formula | C21H29NO3 |
| Molecular Weight | N/A |
| 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 Fingolimod EP Impurity G TFA.
Fingolimod EP Impurity G TFA (CAS CATO-C4X-164619) is a certified pharmaceutical impurity reference standard with the molecular formula C21H29NO3C2HF3O2 and a molecular weight of 457.49 g/mol.
The molecular framework of Fingolimod EP Impurity G TFA (C21H29NO3C2HF3O2) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 certified reference material (CRM), Fingolimod EP Impurity G TFA 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.
Physical & Chemical Properties
| Molecular Formula | C21H29NO3 C2HF3O2 |
| Molecular Weight | 457.49 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at room temperature, 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Fingolimod Standards
- Fingolimod Impurity 18 (CAS 1068-90-2)
- Fingolimod EP Impurity A (CAS 1201794-93-5)
- Fingolimod Palmitate Amide (CAS 1242271-26-6)
- Fingolimod Stearate Amide (CAS 1242271-27-7)
- Fingolimod Impurity 41 (CAS 125574-44-9)
- Fingolimod-D4 Hydrochloride (CAS 1346604-90-7)
- Fingolimod-d4 (CAS 1346747-38-3)
- Fingolimod Impurity 16 (CAS 1404433-87-9)
Recommended Standards
- Propafenone Impurity 33 (CAS CATO-C4X-132233)
- Crizotinib impurity 16 (CAS 877397-65-4)
- Gonadorelin impurity 2 (CAS CATO-C4X-23542)
- 6-Benzyl-3-(2-chlorophenyl)-[1,2,4]triazolo[4,3-a]pyridine (CAS 745826-93-1)
- Dimethyl 4-oxocyclohexane-1,1-dicarboxylate (CAS 58774-03-1)
- Methyl 2-amino-2-cyclohexylacetate hydrochloride (CAS 322392-74-5)
- 5-Morpholinopentanoic acid (CAS 4441-14-9)
- 2-{[4-(4-ethoxyphenyl)-5-(pyridin-3-yl)-4h-1,2,4-triazol-3-yl]sulfanyl}acetic acid (CAS 557064-00-3)
- 3-(3-Methylpyridin-2-yl)propan-1-amine hydrochloride (CAS 1955530-52-5)
- Biotinyl-S6 Phosphate Acceptor Peptide trifluoroacetate salt (CAS 1815618-12-2)
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