| CAS No. | CATO-C4X-1525135 |
| Molecular Formula | C16H18BrNO |
| Molecular Weight | 320.22 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a process- or degradation-related impurity, Formoterol impurity 35 (CAS CATO-C4X-1525135, C16H18BrNO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Formoterol impurity 35 (C16H18BrNO) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, bromine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; 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.
As a certified reference material (CRM), Formoterol impurity 35 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.
| Molecular Formula | C16H18BrNO |
| Molecular Weight | 320.22 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Br-containing |
| Nitrogen Atoms | 1 |