Capecitabine Impurity 18 CAS 71609-08-0
| CAS No. | 71609-08-0 |
| Molecular Formula | C9H12FN3O4 |
| Molecular Weight | 245.21 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Capecitabine Impurity 18 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.
As a process- or degradation-related impurity, Capecitabine Impurity 18 (CAS 71609-08-0, C9H12FN3O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Capecitabine Impurity 18 (C9H12FN3O4) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 5.0, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 245.21 g/mol, it falls into the medium-molecular-weight range. 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), Capecitabine Impurity 18 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 | C9H12FN3O4 |
| Molecular Weight | 245.21 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| 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) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1977 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
Related Capecitabine Standards
- Capecitabine EP Impurity A (CAS 66335-38-4)
- Capecitabine Impurity 16 (CAS CATO-C4X-102416)
- Capecitabine EP Impurity B (CAS 3094-09-5)
- Capecitabine Impurity 28 (CAS 862508-03-0)
- Capecitabine Impurity 19 (CAS CATO-C4X-102419)
- Capecitabine Impurity 12 (CAS 62211-93-2)
- Capecitabine Impurity 14 (CAS 76497-54-6)
- Capecitabine Impurity 41 (CAS CATO-C4X-102441)
Recommended Standards
- Pantoprazole Impurity 58 (CAS CATO-C4X-139958)
- 4-(Methylsulfonyl)-2-Nitrobenzoic Acid (CAS 110964-79-9)
- 4-Amino-1-[(2R,3R,4R,5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one (CAS 10212-20-1)
- Methyl 3-amino-3-[4-(difluoromethoxy)phenyl]propanoate (CAS 1038338-50-9)
- Milrinone Impurity 34 (CAS 1089899-00-2)
- Cefodizime Impurity 7 (CAS CATO-C4X-18067)
- Metoclopramide Impurity 106 (CAS CATO-C4X-1415106)
- 2,2,2-Trifluoro-N-(5-oxo-5,6,7,8-tetrahydro-[1,3]dioxolo[4,5-g]isoquinolin-8-yl)acetamide (CAS 866137-02-2)
- Benzyl ((R)-1-((S)-2-amino-3-methylbutanoyl)pyrrolidin-3-yl)(methyl)carbamate (CAS 1401666-90-7)
- 4-(Trifluoromethyl)phenylethyl bromide (CAS 130365-87-6)
- 2-Fluoro-4-(1-methyl-1h-pyrazol-4-yl)benzaldehyde (CAS 1183623-74-6)
- 4-Chloro-n1-(3-methoxypropyl)benzene-1,2-diamine (CAS 1152589-09-7)
- Methyl 3-(2-ethoxypyridin-3-yl)-3-oxopropanoate (CAS 1229626-75-8)
- Semaglutide impurity 104(Fmoc-D-His-Aib) (CAS 2171211-18-8)
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