| CAS No. | CATO-C4X-124740 |
| Molecular Formula | C18H31NO4 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
CATO supplies Bisoprolol EP Impurity B HCl (CAS CATO-C4X-124740), a pharmacopoeial impurity reference standard (molecular formula C18H31NO4HCl, MW 361.91 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Bisoprolol EP Impurity B HCl is typically white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 361.91 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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.
| Molecular Formula | C18H31NO4 HCl |
| Molecular Weight | 361.91 g/mol |
| Appearance | White to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| 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) | 3.0 |
| UV Absorption | UV-absorbing |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |