Erlotinib Impurity 5 CAS 328528-74-1
| CAS No. | 328528-74-1 |
| Molecular Formula | C20H22BrN3O4 |
| Molecular Weight | 448.31 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Erlotinib Impurity 5 (CAS 328528-74-1, C20H22BrN3O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Erlotinib Impurity 5 (C20H22BrN3O4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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.
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Physical & Chemical Properties
| Molecular Formula | C20H22BrN3O4 |
| Molecular Weight | 448.31 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| 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) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2025 |
| Halogen Content | Br-containing |
| Nitrogen Atoms | 3 |
Related Erlotinib Standards
- Erlotinib Impurity 14 (CAS CATO-C4X-106914)
- Erlotinib Impurity 48 (CAS 2055840-54-3)
- ErlotiniB impurity 37 (CAS CATO-C4X-106937)
- Erlotinib Impurity 7 (CAS 882420-21-5)
- Erlotinib impurity 137 (CAS 1318599-96-0)
- Erlotinib impurity 139 (CAS 2218487-28-4)
- Erlotinib Impurity 15 (CAS CATO-C4X-106915)
- Erlotinib Impurity 91 (CAS 1354727-63-1)
Recommended Standards
- Ethyl 5-(bis(tert-butoxycarbonyl)amino)-4-bromo-1-methyl-1H-imidazole-2-carboxylate (CAS 2764671-66-9)
- (6-(4-(Naphthalen-1-yl)phenyl)pyren-1-yl)boronic acid (CAS 2031254-18-7)
- (4R,4'r)-2,2'-(4-Bromopyridine-2,6-diyl)bis(4-phenyl-4,5-dihydrooxazole) (CAS 618863-43-7)
- 2-((2-((3,4-Dichlorobenzyl)thio)-1-methyl-1H-imidazol-5-yl)methoxy)isoindoline-1,3-dione (CAS 400088-13-3)
- Calcipotriol Impurity 11 (CAS 112849-17-9)
- Ropivacaine EP Impurity E(R-Isomer) (CAS 1050482-18-2)
- Ezetimibe Impurity 83 (CAS 272778-13-9)
- DL-Boc-Phe(4-NH2)-OH (CAS 351208-73-6)
- Benzyl n-[(4,5-dihydro-1h-imidazol-2-yl)methyl]carbamate (CAS 70984-91-7)
- (4-Cyanobenzyl)triphenylphosphonium bromide (CAS 26104-68-7)
- 16993-42-3 Avenaciolide (CAS 16993-42-3)
- N-(4-Ethyl-1H-pyrazol-3-yl)butyramide (CAS 203061-98-7)
- 5-Chloro-1-(2,4-dichlorobenzyl)-2-oxo-N-(4-(trifluoromethyl)phenyl)-1,2-dihydropyridine-3-carboxamide (CAS 242797-26-8)
- D-Ile12-Tirzepatide (CAS CATO-CPTD788921)
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