| CAS No. | CATO-C4X-1814146 |
| Molecular Formula | C10H10Cl4O3 |
| Molecular Weight | 320.00 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 Nintedanib Impurity 146.
As a process- or degradation-related impurity, Nintedanib Impurity 146 (CAS CATO-C4X-1814146, C10H10Cl4O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system, Nintedanib Impurity 146 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 320.00 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
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 | C10H10Cl4O3 |
| Molecular Weight | 320.00 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |