Fluorouracil EP Impurity F CAS 56177-80-1
| CAS No. | 56177-80-1 |
| Molecular Formula | C6H7FN2O2 |
| Molecular Weight | 158.13 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Fluorouracil EP Impurity F (CAS 56177-80-1, C6H7FN2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Fluorouracil EP Impurity F (C6H7FN2O2) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 158.13 g/mol, it falls into the medium-molecular-weight range. 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.
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 | C6H7FN2O2 |
| Molecular Weight | 158.13 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor) |
| Purity | >95% |
| 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) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1973 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 2 |
Related Fluorouracil Standards
- Fluorouracil Impurity 8 (CAS 726207-85-8)
- Fluorouracil Impurity 28 (CAS CATO-C4X-164928)
- Fluorouracil Impurity 23 (CAS CATO-C4X-164923)
- Fluorouracil Impurity 29 (CAS CATO-C4X-164929)
- Fluorouracil Impurity 18 (CAS CATO-C4X-164918)
- Fluorouracil Impurity 11 (Mixture of Diastereomers) (CAS 37103-91-6)
- Fluorouracil EP Impurity E (CAS 1820-81-1)
- Fluorouracil Impurity 26 (CAS 62836-98-0)
Recommended Standards
- Ethyl 4-fluoro-1H-imidazole-5-carboxylate (CAS 33235-31-3)
- 4-Formyl-1,2,3-thiadiazole-5-carboxylic acid (CAS 1934471-23-4)
- methyl 4-fluoro-5-methylfuran-3-carboxylate (CAS 2117692-62-1)
- 2-((1,2,2-Trifluorovinyl)thio)ethan-1-ol (CAS 929971-48-2)
- Erdosteine Impurity 9 (CAS 10593-85-8)
- Deucravacitinib Impurity 5 (CAS CATO-C4X-31385)
- Articaine impurity 24 (CAS 7400-45-5)
- Lysine Impurity 9 (CAS CATO-C4X-22119)
- 3-(Pyridin-4-yl)-4,5,6,7-tetrahydro-1H-pyrazolo[4,3-c]pyridine hydrochloride (CAS 1366053-13-5)
- Methyl 6-bromo-4-fluoro-1H-indazole-3-carboxylate (CAS 1000341-53-6)
- Nabumetone Impurity 28 (CAS 98386-83-5)
- 4-(3-Bromo-2-methylpropyl)-3-chloropyridine (CAS 1484053-02-2)
- 857665-74-8 Methyl L-(1,2,3,4,5,6-~13~C_6_)tyrosinate--hydrogen chloride (1/1) DTXSID50745959 (CAS 857665-74-8)
- Bradykinin-Like Neuropeptide (Aplysia californica) (H-1654.0001) (CAS 165174-60-7)
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