| CAS No. | 1801-06-5 |
| Molecular Formula | C5H4ClFN2O |
| Molecular Weight | 162.55 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Capecitabine Impurity 35.
CATO supplies Capecitabine Impurity 35 (CAS 1801-06-5), a pharmacopoeial impurity reference standard (molecular formula C5H4ClFN2O, MW 162.55 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution, Capecitabine Impurity 35 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 162.55 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
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.
| Molecular Formula | C5H4ClFN2O |
| Molecular Weight | 162.55 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, 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 |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 1957 |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 2 |