Afatinib Impurity 8 CAS CATO-C4X-10068
| CAS No. | CATO-C4X-10068 |
| Molecular Formula | C22H19BrClFN4O3 |
| Molecular Weight | 521.77 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Afatinib Impurity 8.
As a process- or degradation-related impurity, Afatinib Impurity 8 (CAS CATO-C4X-10068, C22H19BrClFN4O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Afatinib Impurity 8 (C22H19BrClFN4O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine/bromine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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).
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.
As a certified reference material (CRM), Afatinib Impurity 8 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 | C22H19BrClFN4O3 |
| Molecular Weight | 521.77 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 | F/Cl/Br-containing |
| Nitrogen Atoms | 4 |
Related Afatinib Standards
- Afatinib Impurity 48 (CAS 3005278-77-0)
- Afatinib Impurity 33 (CAS CATO-C4X-100633)
- Afatinib Impurity 47 (CAS CATO-C4X-100647)
- Afatinib Impurity 26 (CAS CATO-C4X-100626)
- Afatinib dichloro impurity (CAS 2223677-63-0)
- Afatinib Impurity 4 (CAS CATO-C4X-10064)
- Afatinib Impurity 11 (CAS CATO-C4X-100611)
- Afatinib Impurity 57 (CAS CATO-C4X-100657)
Recommended Standards
- N-(4-Hydroxy)benzyl O-tert-Butyldimethylsilyl Ractopamine (CAS 1797883-87-4)
- 6-Chloro-3-iodo-1-trityl-1H-pyrazolo[4,3-c]pyridine, 97% (CAS 1431719-88-8)
- Lefamulinum Impurity 32 (CAS CATO-C4X-304732)
- 2-Chloro-7-iodo-5-(triphenylmethyl)-5H-pyrrolo[2,3-b]pyrazine (CAS 1509941-37-0)
- Bosutinib Impurity 2 (CAS CATO-C4X-18472)
- Lisinopril Impurity 16 (CAS CATO-C4X-168116)
- Nintedanib Impurity 163 (CAS CATO-C4X-1814163)
- 2-Chloro-N-isopropyl-N-(pyrazin-2-ylmethyl)acetamide (CAS 1353948-24-9)
- 3,6-Dichloro-4,5-diethylpyridazine (CAS 107228-53-5)
- Methyl 1-cyclopropyl-7-methyl-4-oxo-2-thioxo-1,2,3,4-tetrahydropyrido[2,3-d]pyrimidine-5-carboxylate (CAS 938012-31-8)
- 7-Nitro-1,3,5-triazaadamantane (CAS 14612-28-3)
- 2-Azabicyclo[2.2.1]heptane-2-carboxamide (CAS 1249920-60-2)
- 4'-(Ethoxycarbonyl)-[1,1'-biphenyl]-4-carboxylic acid (CAS 80911-54-2)
- Gastric Inhibitory Polypeptide (6-30) amide (human) (CAS 1139691-72-7)
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