Gefitinib Impurity 54 CAS 675126-26-8
| CAS No. | 675126-26-8 |
| Molecular Formula | C15H19N3O5 |
| Molecular Weight | 321.33 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 321.33 g/mol gives Gefitinib Impurity 54 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Gefitinib Impurity 54 (CAS 675126-26-8) is a certified pharmaceutical impurity reference standard with the molecular formula C15H19N3O5 and a molecular weight of 321.33 g/mol.
Structurally, Gefitinib Impurity 54 (C15H19N3O5) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 321.33 g/mol, it falls into the moderately-high-molecular-weight range. 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 54 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 | C15H19N3O5 |
| Molecular Weight | 321.33 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°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) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1985 |
| Nitrogen Atoms | 3 |
Related Gefitinib Standards
- Gefitinib Impurity 48 (CAS 1006378-06-8)
- Gefitinib impurity 68 (CAS CATO-C4X-111768)
- Gefitinib impurity 69 (CAS CATO-C4X-111769)
- Gefitinib Impurity 89 (CAS CATO-C4X-111789)
- Gefitinib Impurity 7 (CAS 184475-71-6)
- Gefitinib impurity 64 (CAS CATO-C4X-111764)
- Gefitinib EP Impurity A (CAS 199327-61-2)
- Gefitinib Impurity 41 (CAS CATO-C4X-111741)
Recommended Standards
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- Tetrahydro-1,1-dioxido-3-thienyl 4-nitrobenzenesulfonate (CAS 62671-90-3)
- Perospirone impurity 49 (CAS CATO-C4X-245849)
- Cariprazine Impurity 22 (CAS 1480744-31-7)
- Cabozantinib Impurity 21 (CAS 190728-25-7)
- 4-(3-Methoxybenzoyl)quinoline (CAS 1706450-30-7)
- rac-2-[(1R,2S)-2-phenylcyclopropyl]acetonitrile (CAS 1821769-92-9)
- 2-(4-Chlorophenyl)-2-oxoethyl 2-(4-heptylphenyl)-8-methylquinoline-4-carboxylate (CAS 355433-26-0)
- 1-((6-Chloropyridin-3-yl)methyl)-N-methylpiperidin-4-amine hydrochloride (CAS 1289387-41-2)
- Elagolix Impurity 24 (CAS CATO-C4X-206824)
- 1-(1-(Difluoromethyl)-1H-pyrazol-5-yl)-N-((1-ethyl-1H-pyrazol-4-yl)methyl)methanamine hydrochloride (CAS 1855939-03-5)
- Tau Peptide (268-282) trifluoroacetate salt (CAS 330456-37-6)
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