Gefitinib Impurity 21 HCl CAS 184475-68-1
| CAS No. | 184475-68-1 |
| Molecular Formula | C22H24F2N4O3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Gefitinib Impurity 21 HCl (CAS 184475-68-1, C22H24F2N4O3HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Gefitinib Impurity 21 HCl (C22H24F2N4O3HCl) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/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. 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.
As a certified reference material (CRM), Gefitinib Impurity 21 HCl 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 | C22H24F2N4O3 HCl |
| Molecular Weight | 466.91 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2009 |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 4 |
Related Gefitinib Standards
- Gefitinib Impurity 48 (CAS 1006378-06-8)
- Gefitinib-d3 (CAS 1173976-40-3)
- Gefitinib-d8 (CAS 1228664-49-0)
- Gefitinib Impurity 28 (CAS 1379208-77-1)
- Gefitinib Impurity 1 (CAS 1502829-45-9)
- Gefitinib Impurity 19 (CAS 153437-78-6)
- Gefitinib Impurity 58 DiHCl (CAS 1561173-24-7（1*HCl Salt)）)
- Gefitinib Impurity 10 (CAS 1603814-04-5)
Recommended Standards
- Ampicillin Impurity 98 (CAS 49841-96-5)
- Palbociclib Impurity 111 (CAS 571189-16-7)
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- 1-Chloro-2-butanone (CAS 616-27-3)
- 1-(3-Iodophenyl)-2,5-dimethyl-1H-pyrrole (CAS 217314-37-9)
- CP 465022 (2Z)-2-butenedioate (CAS 199656-46-7)
- 3-Methyl-6-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)pyrimidin-4(3H)-one (CAS 2866420-51-9)
- 1-[(1-Imidazolyl)sulfonyl]-4-methylpiperazine (CAS 1823876-66-9)
- [Nva12]-Tirzepatide (CAS CATO-C4X-324042)
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