| CAS No. | CATO-C4X-13397 |
| Molecular Formula | C19H28NO3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
CATO supplies Umeclidinium Impurity 7 (CAS CATO-C4X-13397), a pharmacopoeial impurity reference standard (molecular formula C19H28NO3Br, MW 398.34 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution, Umeclidinium Impurity 7 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 398.34 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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), Umeclidinium Impurity 7 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 | C19H28NO3 Br |
| Molecular Weight | 398.34 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Br-containing |
| Nitrogen Atoms | 1 |