Capecitabine EP Impurity C CAS 161599-46-8
| CAS No. | 161599-46-8 |
| Molecular Formula | C13H16FN3O6 |
| Molecular Weight | 329.28 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Based on its molecular formula C13H16FN3O6, Capecitabine EP Impurity C contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 329.28 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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).
As a process- or degradation-related impurity, Capecitabine EP Impurity C (CAS 161599-46-8, C13H16FN3O6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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 | C13H16FN3O6 |
| Molecular Weight | 329.28 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2003 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
Related Capecitabine Standards
- Capecitabine Impurity 10 (CAS 2230479-30-6)
- Capecitabine Impurity 56 (CAS CATO-C4X-102456)
- Capecitabine Impurity 42 (CAS CATO-C4X-102442)
- Capecitabine Impurity 40 (CAS 5636-04-4)
- Capecitabine Impurity 37 (CAS CATO-C4X-102437)
- Capecitabine Impurity 47 (CAS CATO-C4X-102447)
- Capecitabine Impurity 48 (CAS CATO-C4X-102448)
- Capecitabine Impurity 27 (CAS 13007-50-6)
Recommended Standards
- 4-Fluoro-3-[(6-methoxyimidazo[1,2-a]pyridine-3-carbonyl)amino]benzoic acid (CAS 2088942-45-2)
- Trifarotene impurity 27 (CAS CATO-C4X-313227)
- 3-Hydroxyflunitrazepam (CAS 67739-71-3)
- Methyl 3-((dinitrilomethyl)diazenyl)-5-nitrobenzo[b]thiophene-2-carboxylate (CAS 1025634-76-7)
- Prasugrel Impurity 17 (CAS 109904-25-8)
- Cefmenoxime Impurity 11 (CAS CATO-C4X-147711)
- Avibactam Impurity 59 (CAS CATO-C4X-134859)
- 1,2-Dibenzoyl-1-tert-butylhydrazine (CAS 112225-87-3)
- N-(4-chlorobenzyl)-2-((3-ethyl-4-oxo-7-phenyl-3,4-dihydrothieno[3,2-d]pyrimidin-2-yl)thio)acetamide (CAS 1223950-81-9)
- 3-(2,3,5,6-Tetramethylbenzoyl)-acrylic Acid (CAS 22659-83-2)
- Ethyl 4-(4-cyanophenyl)-2-methyl-6-oxo-1,4,5,6-tetrahydropyridine-3-carboxylate (CAS 294853-59-1)
- 3-(3-Chloro-5-fluorophenyl)-3,4,5-trifluoropropiophenone (CAS 898751-56-9)
- 2-(Pyridin-4-yl)acetimidamide (CAS 885953-93-5)
- Liraglutide Impurity 20 TFA Salt (CAS CATO-C4X-199220)
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