Leflunomide EP Impurity C CAS 61643-23-0
| CAS No. | 61643-23-0 |
| Molecular Formula | C12H9F3N2O2 |
| Molecular Weight | 270.21 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Leflunomide EP Impurity C is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Leflunomide EP Impurity C (CAS 61643-23-0) is a certified pharmaceutical impurity reference standard with the molecular formula C12H9F3N2O2 and a molecular weight of 270.21 g/mol.
Leflunomide EP Impurity C (C12H9F3N2O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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), Leflunomide EP Impurity C 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 | C12H9F3N2O2 |
| Molecular Weight | 270.21 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >90% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1974 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 2 |
Related Leflunomide Standards
- Leflunomide (CAS 75706-12-6)
- Leflunomide EP Impurity E (CAS 208401-20-1)
- Leflunomide EP Impurity F (CAS 1403564-06-6)
- Leflunomide EP Impurity B (Teriflunomide) (CAS 163451-81-8)
- Leflunomide-d4 (CAS 1189987-23-2)
- Leflunomide EP Impurity B-d4 (Teriflunomide-d4) (CAS 1185240-22-5)
- Leflunomide Impurity 20 (CAS 2734292-21-6)
- Leflunomide Impurity 2 (CAS 827029-20-9)
Recommended Standards
- Nilotinib Impurity 16 (CAS 641571-13-3)
- Bicalutamide Impurity 14 (Bicalutamide Epoxide Impurity) (CAS 90357-51-0)
- 5-Ethynyl-1-(3-fluoro-4-hydroxy-5-hydroxymethyl-tetrahydro-furan-2-yl)-1H-pyrimidine-2,4-dione 5-ethynyl-1-[(2R,3S,4R,5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]pyrimidine-2,4-dione 95740-26-4 (CAS 95740-26-4)
- Teriflunomide Impurity 5 (CAS 220512-86-7)
- LysoPE impurity 7 (CAS 92605-66-8)
- Nilotinib Impurity 42 (CAS CATO-C4X-125642)
- Valsartan Impurity 100 (CAS CATO-C4X-1057100)
- 2,6-Dibromoquinazolin-8-ol (CAS 953040-59-0)
- 2-Bromo-N-(4-chloro-3-nitrophenyl)acetamide (CAS 349120-95-2)
- (R)-2-Amino-2-(2-naphthyl)ethanol (CAS 204851-80-9)
- (4,5,6,7-Tetrahydropyrazolo[1,5-a]pyridin-2-yl)methanol (CAS 623564-49-8)
- 2-(2-((tert-Butoxycarbonyl)(cyclopropylmethyl)amino)pyridin-4-yl)oxazole-4-carboxylic acid (CAS 1287670-29-4)
- 1-(3-Chloro-2-hydroxy-5-methylphenyl)ethan-1-one (CAS 7507-88-2)
- Semaglutide impurity 81 (CAS CATO-C4X-222681)
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