Ipratropium Bromide EP Impurity B CAS 58073-59-9
| CAS No. | 58073-59-9 |
| Molecular Formula | C20H30NO3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ipratropium Bromide EP Impurity B.
As a process- or degradation-related impurity, Ipratropium Bromide EP Impurity B (CAS 58073-59-9, C20H30NO3Br) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C20H30NO3Br, Ipratropium Bromide EP Impurity B contains a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 412.37 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 | C20H30NO3 Br |
| Molecular Weight | 412.37 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store at room temperature, 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 |
| CAS Registry Year (est.) | 1973 |
| Halogen Content | Br-containing |
| Nitrogen Atoms | 1 |
Related Ipratropium Standards
- Ipratropium Impurity 24 (Mixture of Isomers) (CAS 17812-46-3)
- Ipratropium Impurity 17 (CAS 17838-69-6)
- (S)-Ipratropium Bromide EP Impurity E Formate (CAS 183626-76-8)
- Ipratropium Bromide EP Impurity E (CAS 22235-81-0)
- Ipratropium Bromide (CAS 22254-24-6)
- Ipratropium Impurity 30 (CAS 259092-15-4)
- Ipratropium Bromide Impurity 33 (CAS 2784-21-6)
- Ipratropium Impurity 31 (CAS 3423-25-4)
Recommended Standards
- Lesinurad Impurity 9 (CAS CATO-C4X-14789)
- Iomeprol Impurity 11 (CAS CATO-C4X-182011)
- Amorolfine EP impurity M HCl (CAS CATO-C4X-154221)
- 2-(5-Chloro-2-methoxypyridin-4-yl)propanoic acid (CAS 2357670-62-1)
- 6-(Aminomethyl)-5-cyclopropoxy-N-methylnicotinamide (CAS 1243440-80-3)
- 1-(2,4-Dichlorophenyl)-1h-pyrazol-4-amine (CAS 14044-29-2)
- 2-(Difluoromethyl)-4,5-dimethoxypyridine-3-sulfonyl chloride (CAS 1804454-17-8)
- 4-[(3-Fluorophenyl)methyl]-2H,3H,4H,5H-thieno[3,2-f][1,4]thiazepin-5-one (CAS 478080-77-2)
- Ethyl 3-bromo-4,5-dihydroisoxazole-5-carboxylate (CAS 823787-15-1)
- Semaglutide impurity 199 (CAS CATO-C4X-2226199)
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