Afatinib Impurity 83 CAS CATO-C4X-100683
| CAS No. | CATO-C4X-100683 |
| Molecular Formula | C16H14ClFN4O |
| Molecular Weight | 332.76 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Afatinib Impurity 83 (CAS CATO-C4X-100683) is a certified pharmaceutical impurity reference standard with the molecular formula C16H14ClFN4O and a molecular weight of 332.76 g/mol.
Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution, Afatinib Impurity 83 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 332.76 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 | C16H14ClFN4O |
| Molecular Weight | 332.76 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light |
| 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) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 4 |
Related Afatinib Standards
- Afatinib Impurity 81 (CAS CATO-C4X-100681)
- Afatinib Impurity 53 (CAS 1449430-45-8)
- Afatinib Impurity 22 (CAS 162012-67-1)
- Afatinib Impurity 51 (CAS CATO-C4X-100651)
- Afatinib Impurity 54 (CAS 2831861-00-6)
- Afatinib Impurity 80 (CAS CATO-C4X-100680)
- Afatinib Impurity 65 (CAS CATO-C4X-100665)
- Afatinib Impurity 76 (CAS CATO-C4X-100676)
Recommended Standards
- N-(4-chlorophenyl)-5-nitrobenzo[b]thiophene-2-carboxamide (CAS 478248-41-8)
- N-Nitroso Midazolam EP Impurity E (CAS CATO-C4X-150938)
- N-(4-Chlorophenyl)-5-(4-nitrophenyl)-1,3,4-thiadiazol-2-amine (CAS 664973-39-1)
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- Tofacitinib Impurity 182 (CAS 1053228-28-6)
- Ibuprofen Impurity 75 (CAS 51407-46-6)
- Tivozanib Impurity 17 (CAS CATO-C4X-340017)
- 13-ethyl-10b-hydroxy-gon-4-ene-3,17-dione 13407-77-7 (CAS 13407-77-7)
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