Afatinib Impurity 13 CAS CATO-C4X-100613
| CAS No. | CATO-C4X-100613 |
| Molecular Formula | C18H16F2N4O2 |
| Molecular Weight | 358.34 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Afatinib Impurity 13 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Afatinib Impurity 13 (CAS CATO-C4X-100613, C18H16F2N4O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C18H16F2N4O2, Afatinib Impurity 13 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 358.34 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.
As a certified reference material (CRM), Afatinib Impurity 13 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C18H16F2N4O2 |
| Molecular Weight | 358.34 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, 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) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 4 |
Related Afatinib Standards
- Afatinib Impurity 29 (CAS 1456696-14-2)
- Afatinib Impurity 9 (CAS CATO-C4X-10069)
- Afatinib Impurity 69 (CAS CATO-C4X-100669)
- Afatinib Impurity 82 (CAS CATO-C4X-100682)
- Afatinib Impurity 20 (CAS 179552-73-9)
- Afatinib Impurity 91 (CAS 2512206-82-3)
- Afatinib Impurity 41 (CAS 179552-74-0)
- Afatinib Impurity 2 (CAS 314771-76-1)
Recommended Standards
- 345637-86-7 1-[4-(Difluoromethoxy)phenyl]-2,3,4,9-tetrahydro-1H-beta-carboline-3-carboxylic acid MFCD02089324 (CAS 345637-86-7)
- Sweroside (CAS 14215-86-2)
- Tert-butyl 3,3-difluoro-4-(4-nitrophenoxy)piperidine-1-carboxylate (CAS 2101206-39-5)
- Gardenin B (CAS 2798-20-1)
- Valaciclovir EP Impurity R (CAS 142963-59-5)
- Citicoline Impurity 18 (CAS CATO-C4X-220318)
- Mirogabalin Impurity 170 (CAS CATO-C4X-2924170)
- 2-(2-bromophenyl)-2-methoxyacetic acid (CAS 1545579-53-0)
- 4-(4-Methylbenzamido)butanoic acid (CAS 223465-84-7)
- 4-((Methylamino)methyl)benzoic acid (CAS 96084-38-7)
- 3-(Benzyloxy)-4-fluoro-5-(methylthio)benzoic acid (CAS 2635937-57-2)
- 4-(Methylthio)benzo[d]isoxazol-3-amine (CAS 1228574-44-4)
- Norfloxacin Impurity 55 (CAS CATO-C4X-146855)
- C-Peptide (human) (CAS 33017-11-7)
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