Capecitabine Impurity 55 CAS CATO-C4X-102455
| CAS No. | CATO-C4X-102455 |
| Molecular Formula | C11H16O7 |
| Molecular Weight | 260.24 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 process- or degradation-related impurity, Capecitabine Impurity 55 (CAS CATO-C4X-102455, C11H16O7) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C11H16O7, Capecitabine Impurity 55 contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 260.24 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C11H16O7 |
| Molecular Weight | 260.24 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | ≥95% |
| Storage | Store in a cool place (≤25°C), keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
Related Capecitabine Standards
- Capecitabine Impurity 12 (CAS 62211-93-2)
- Capecitabine Impurity 14 (CAS 76497-54-6)
- Capecitabine Impurity 41 (CAS CATO-C4X-102441)
- Capecitabine Impurity 19 (CAS CATO-C4X-102419)
- Capecitabine Impurity 11 (CAS 111878-21-8)
- Capecitabine EP Impurity B (CAS 3094-09-5)
- Capecitabine EP Impurity A (CAS 66335-38-4)
- Capecitabine Impurity 16 (CAS CATO-C4X-102416)
Recommended Standards
- Amorolfine Impurity 123 (CAS CATO-C4X-1236123)
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- Enzalutamide Impurity 15 (CAS 1895865-10-7)
- Lemborexant Impurity 34 (CAS 1369765-95-6)
- Safinamide Impurity 17 (CAS 1205608-96-3)
- Terbinafine impurity 41 (CAS CATO-C4X-133841)
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