Gefitinib Impurity 31 CAS CATO-C4X-111731
| CAS No. | CATO-C4X-111731 |
| Molecular Formula | C28H42N4O6S2 |
| Molecular Weight | 594.79 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Gefitinib Impurity 31 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.
As a process- or degradation-related impurity, Gefitinib Impurity 31 (CAS CATO-C4X-111731, C28H42N4O6S2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Gefitinib Impurity 31 (C28H42N4O6S2) is characterized by a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. 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. 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.
Physical & Chemical Properties
| Molecular Formula | C28H42N4O6S2 |
| Molecular Weight | 594.79 g/mol |
| Purity | >95% |
| 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 |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 4 |
| Sulfur Atoms | 2 |
Related Gefitinib Standards
- Gefitinib Impurity 95 (CAS CATO-C4X-111795)
- Gefitinib impurity 65 (CAS CATO-C4X-111765)
- Gefitinib Impurity 96 (CAS CATO-C4X-111796)
- Gefitinib Impurity 1 (CAS 1502829-45-9)
- Gefitinib Impurity 84 (CAS CATO-C4X-111784)
- Gefitinib Impurity 52 (CAS CATO-C4X-111752)
- Gefitinib Impurity 17 (CAS CATO-C4X-111717)
- Gefitinib Impurity 4 (CAS 2089650-13-3)
Recommended Standards
- 1,1',1''-((2,4,6-Trimethylbenzene-1,3,5-triyl)tris(methylene))tris(5,6-dimethyl-1H-benzo[d]imidazole) (CAS 1673560-52-5)
- Atrasentan Impurity 100 (CAS 1059043-95-6)
- Phosphorous acid diisooctyl phenyl ester (CAS 26544-22-9)
- Atrasentan Impurity 102 (CAS 1059052-05-9)
- Trazodone impurity 56 (CAS CATO-C4X-177256)
- Upadacitinib Impurity 181 (CAS CATO-C4X-2405181)
- Capivasertib Impurity 37 (CAS CATO-C4X-331237)
- 3-Cyclopropyl-1-propyl-1H-pyrazole (CAS 1170291-25-4)
- 2',4'-Dihydroxydihydrochalcone (CAS 53596-71-7)
- Alimemazine Tartrate (CAS 4330-99-8)
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- 2-(4-Methoxy-2-methylphenyl)ethanamine (CAS 910391-08-1)
- 6-(Aminomethyl)benzo[b]thiophene 1,1-dioxide (CAS 1186519-56-1)
- Lixisenatide (CAS 320367-13-3)
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