Afatinib Impurity 4 CAS CATO-C4X-10064
| CAS No. | CATO-C4X-10064 |
| Molecular Formula | C24H25Cl2N5O3 |
| Molecular Weight | 502.39 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Afatinib Impurity 4 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Afatinib Impurity 4 (CAS CATO-C4X-10064) is a certified pharmaceutical impurity reference standard with the molecular formula C24H25Cl2N5O3 and a molecular weight of 502.39 g/mol.
The molecular framework of Afatinib Impurity 4 (C24H25Cl2N5O3) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.
Physical & Chemical Properties
| Molecular Formula | C24H25Cl2N5O3 |
| Molecular Weight | 502.39 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| 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) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 5 |
Related Afatinib Standards
- Afatinib dichloro impurity (CAS 2223677-63-0)
- Afatinib Impurity 11 (CAS CATO-C4X-100611)
- Afatinib Impurity 57 (CAS CATO-C4X-100657)
- Afatinib Impurity 87 (CAS CATO-C4X-100687)
- Afatinib-d6 (CAS 1313874-96-2)
- Afatinib Impurity 47 (CAS CATO-C4X-100647)
- Afatinib Impurity 36 (CAS CATO-C4X-100636)
- Afatinib Impurity 63 (CAS CATO-C4X-100663)
Recommended Standards
- 310392-94-0 QM05G7NM4H MIN-117 free base UNII-QM05G7NM4H (alphaS)-4-(3,4-Dichlorophenyl)-alpha-(((2-(5-methyl-1,3,4-oxadiazol-2-yl)-4-benzofuranyl)oxy)methyl)-1-piperidineethanol 1-Piperidineethanol, 4-(3,4-dichlorophenyl)-alpha-(((2-(5-methyl-1,3,4-oxadiazol-2-yl)-4-benzofuranyl)oxy)methyl)-, (alphaS)- (CAS 310392-94-0)
- Bosutinib Impurity 21 (CAS CATO-C4X-184721)
- Clofazimine Impurity 22 (CAS CATO-C4X-207122)
- (S)-6-(3-(tert-Butyl)-5-(3-(2,3-dichlorophenyl)ureido)-1H-pyrazol-1-yl)-1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid (CAS 897369-18-5)
- Pranoprofen Impurity 17 (CAS CATO-C4X-181117)
- Elagolix Impurity 69 (CAS CATO-C4X-206869)
- Etapenem Impurity 45 (CAS CATO-C4X-163345)
- Tert-butyl ((1-(pyrimidin-2-yl)piperidin-4-yl)methyl)carbamate (CAS 1365988-45-9)
- Lead(II) formate (CAS 811-54-1)
- Tert-butyl 2-(cyclobutanecarbonyl)pyrrolidine-1-carboxylate (CAS 1781535-10-1)
- (3-(Benzyloxy)phenyl)pentafluoro-lambda6-sulfane (CAS 1272542-25-2)
- Ethyl 4-Piperidineacetate Hydrochloride (CAS 169458-04-2)
- 5-Methoxychroman-2-one (CAS 82243-02-5)
- Semaglutide impurity 60 (CAS CATO-C4X-222660)
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