Gefitinib impurity 02 CAS 184475-50-1
| CAS No. | 184475-50-1 |
| Molecular Formula | C22H24F2N4O3 |
| Molecular Weight | 430.45 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 process- or degradation-related impurity, Gefitinib impurity 02 (CAS 184475-50-1, C22H24F2N4O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Gefitinib impurity 02 (C22H24F2N4O3) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
As a certified reference material (CRM), Gefitinib impurity 02 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 |
| Molecular Weight | 430.45 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) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2009 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 4 |
Related Gefitinib Standards
- Gefitinib Impurity 42 (CAS CATO-C4X-111742)
- Gefitinib Impurity 8 (CAS 847949-49-9)
- Gefitinib Impurity 98 (CAS CATO-C4X-111798)
- Gefitinib Impurity 14 (CAS 847949-56-8)
- Gefitinib Impurity 38 (CAS 847949-50-2)
- Gefitinib (CAS 184475-35-2)
- Gefitinib Impurity 10 (CAS 1603814-04-5)
- Gefitinib Impurity 33 (CAS 909863-33-8)
Recommended Standards
- (1S)-2,2′-Bis(methoxymethoxy)[1,1′-binaphthalene]-3,3′-dicarboxaldehyde (CAS 176437-91-5)
- N-(Butoxycarbonyl)-3-[[2-[(5R)-3-(4-cyanophenyl)-4,5-dihydro-5-isoxazolyl]acetyl]amino]-,methyl esterL-alanine (CAS 188016-51-5)
- Azilsartan Impurity N2 (CAS 1675221-59-6)
- Thalidomide-O-amido-C6-NH2 (CAS 1950635-13-8)
- Metformin EP Impurity B Dinitrate (CAS 27369-26-2)
- Sofosbuvir Impurity 57 (CAS 1337529-56-2)
- Eszopiclone Impurity 6 (CAS 1122549-43-2)
- 6-(4-Fluoro-3-(trifluoromethyl)phenyl)picolinaldehyde (CAS 1401165-65-8)
- 4-Bromo-N-(thieno[2,3-d]pyrimidin-4-yl)benzamide (CAS 1003159-87-2)
- Methyl 3-4-O-isopropylidene-β-L-erythro-pentopyranosid-2-ulose (CAS 4096-62-2)
- 4-(5-Amino-1h-1,3-benzodiazol-2-yl)-2-methoxyphenol (CAS 893611-77-3)
- 1-(2-Chloro-4-nitrophenyl)-3-methylpiperazine hydrochloride (CAS 299425-75-5)
- 1-(4-Chlorophenyl)-2,2-dimethylpropan-1-one (CAS 30314-42-2)
- Semaglutide Impurity 130 (CAS 1188328-40-6)
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