Leflunomide EP Impurity A CAS 455-14-1
| CAS No. | 455-14-1 |
| Molecular Formula | C7H6F3N |
| Molecular Weight | 161.12 g/mol |
| 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 Leflunomide EP Impurity A.
CATO supplies Leflunomide EP Impurity A (CAS 455-14-1), a pharmacopoeial impurity reference standard (molecular formula C7H6F3N, MW 161.12 g/mol) used for the identification and quantification of trace impurities in APIs.
Based on its molecular formula C7H6F3N, Leflunomide EP Impurity A contains a nitrile group, fluorine substitution, an aromatic ring system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 161.12 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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.
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 | C7H6F3N |
| Molecular Weight | 161.12 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Leflunomide Standards
- Leflunomide Impurity 19 (CAS 51135-73-0)
- Leflunomide Impurity 17 (CAS 67305-24-2)
- Leflunomide Impurity 14 (CAS 51145-57-4)
- Leflunomide Impurity 3 (CAS 2772495-33-5)
- Leflunomide Impurity 7 (CAS 88511-40-4)
- Leflunomide Impurity 18 (CAS 17153-20-7)
- Leflunomide EP Impurity D (CAS 42831-50-5)
- Leflunomide Impurity 15 (CAS 4637-24-5)
Recommended Standards
- Milrinone Impurity 35 (CAS 52600-51-8)
- Flutamide Impurity 7 (CAS 88-17-5)
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- 3-Aminobenzotrifluoride (CAS 98-16-8)
- Lornoxicam impurity 48 (CAS 126910-68-7)
- Alogliptin Impurity 53 (CAS CATO-C4X-109953)
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- Des-Phe22-Tirzepatide (CAS CATO-CPTD788951)
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