Gefitinib Impurity N18 CAS 58749-47-6
| CAS No. | 58749-47-6 |
| Molecular Formula | C8H7NO5 |
| Molecular Weight | 197.14 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 197.14 g/mol gives Gefitinib Impurity N18 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
As a process- or degradation-related impurity, Gefitinib Impurity N18 (CAS 58749-47-6, C8H7NO5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C8H7NO5, Gefitinib Impurity N18 contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 197.14 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 N18 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 | C8H7NO5 |
| Molecular Weight | 197.14 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1973 |
| Nitrogen Atoms | 1 |
Related Gefitinib Standards
- Gefitinib Impurity 18 (CAS 50413-44-0)
- Gefitinib Impurity 28 (CAS 1379208-77-1)
- Gefitinib Impurity 4 (CAS 179688-52-9)
- Gefitinib Impurity 8 (CAS 379228-50-9)
- Gefitinib Impurity 85 (CAS CATO-C4X-111785)
- Gefitinib Impurity 34 (CAS 194423-17-1)
- Gefitinib Impurity 92 (CAS CATO-C4X-111792)
- Gefitinib Impurity 45 (CAS 350-30-1)
Recommended Standards
- Entacapone Impurity N5 (CAS 2426-86-0)
- 2-Hydroxy-5-nitro-m-anisaldehyde (CAS 17028-61-4)
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- 2-hydroxy-3-methoxy-4-nitrobenzaldehyde (CAS 20041-61-6)
- Fluconazole Impurity 27 (CAS CATO-C4X-101927)
- Atorvastatin Impurity 93 (CAS 163217-74-1)
- Daptomycin Impurity 44 (CAS CATO-C4X-137844)
- (5-(4,4,5,5-Tetramethyl-1,3,2-dioxaborolan-2-yl)pyridin-3-yl)methanamine (CAS 1976012-69-7)
- 4,4,7-Trimethyl-3,4-dihydroquinolin-2(1H)-one (CAS 133999-05-0)
- Sofosbuvir Impurity 33 (CAS CATO-C4X-105233)
- 5-ethyl-1-[(4-fluorophenyl)methyl]-1H-1,2,3-triazol-4-amine hydrochloride (CAS 1798728-30-9)
- tert-Butyl (3-fluoro-5-methylphenyl)carbamate (CAS 1516512-89-2)
- 1',2'-Dihydrospiro[azetidine-3,3'-indole]-2'-onehydrochloride (CAS 1795735-26-0)
- (2S)-2-amino-4-(hydroxymethylphosphinyl)butanoyl-L-alanyl-L-alanine (2S)-2-amino-4-[hydroxy(methyl)phosphinoyl]butyryl-L-alanyl-L-alanine 2-Amino-4-(methylphosphino)butyrylalanylalanine 35597-43-4 Antibiotic SF 1293 Bialaphos CHEBI:3088 L-phosphinothricyl-L-alanyl-L-alanine N-{(2S)-2-amino-4-[hydroxy(methyl)phosphoryl]butanoyl}-L-alanyl-L-alanine PTT Phosphinothricylalanylalanine bilanafos gamma-(Hydroxymethylphosphinyl)-L-alpha-aminobutyryl-L-alanyl-L-alanine phosphinothricin tripeptide (CAS 35597-43-4)
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