Nintedanib Impurity 138 CAS CATO-C4X-1814138
| CAS No. | CATO-C4X-1814138 |
| Molecular Formula | C10H12Cl2O3 |
| Molecular Weight | 251.11 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Nintedanib Impurity 138 (CAS CATO-C4X-1814138) is a certified pharmaceutical impurity reference standard with the molecular formula C10H12Cl2O3 and a molecular weight of 251.11 g/mol.
The molecular framework of Nintedanib Impurity 138 (C10H12Cl2O3) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C10H12Cl2O3 |
| Molecular Weight | 251.11 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, keep tightly closed to prevent evaporation |
| 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 |
Related Nintedanib Standards
- Nintedanib Impurity 135 (CAS CATO-C4X-1814135)
- Nintedanib Impurity 137 (CAS CATO-C4X-1814137)
- Nintedanib Impurity 139 (CAS CATO-C4X-1814139)
- Nintedanib Impurity 141 (CAS CATO-C4X-1814141)
- Nintedanib Impurity 142 (CAS CATO-C4X-1814142)
- Nintedanib Impurity 31 (CAS 2514952-69-1)
- Nintedanib Impurity 11 (CAS CATO-C4X-181411)
- Nintedanib Impurity 25 (CAS 262368-25-2)
Recommended Standards
- 1,2-Bis(4-chlorophenyl)diazene (CAS 1602-00-2)
- 89976-15-8 7-iodo-1H-indole DTXSID00453092 (CAS 89976-15-8)
- 2,4′-Dichlorobenzophenone (CAS 85-29-0)
- Phenacetin Impurity 16 (CAS 30926-04-6)
- Efinaconazole Impurity 25 (CAS 2055912-03-1)
- Rivaroxaban Impurity N6 (CAS 5466-93-3)
- Rosuvastatin Impurity 257 (CAS CATO-C4X-1169257)
- Lemborexant Impurity 64 (CAS CATO-C4X-304264)
- 4-(2,6-Diethyl-phenyl)-5-pyridin-3-yl-4H-[1,2,4]triazole-3-thiol (CAS 380442-83-1)
- 5-Bromo-4,6-dichloro-2-(methylthio)pyrimidine (CAS 98136-20-0)
- 2-(Cyclopropyl(2-iodobenzyl)amino)acetic acid (CAS 1353985-84-8)
- 1-Fluoro-4-(4-methylpent-4-en-1-yl)benzene (CAS 74646-35-8)
- 3-([1,1'-Biphenyl]-4-yl)-4-hydroxy-1H-pyrrole-2,5-dione (CAS 77529-41-0)
- Tau Peptide (295-309) trifluoroacetate salt (CAS 330456-46-7)
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