Ipratropium Bromide EP Impurity F CAS 60018-35-1
| CAS No. | 60018-35-1 |
| Molecular Formula | C20H28NO2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Ipratropium Bromide EP Impurity F (CAS 60018-35-1, C20H28NO2Br) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Ipratropium Bromide EP Impurity F (C20H28NO2Br) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 394.35 g/mol, it falls into the moderately-high-molecular-weight range. 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.
Physical & Chemical Properties
| Molecular Formula | C20H28NO2 Br |
| Molecular Weight | 394.35 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 |
| 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1974 |
| 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
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- (3-Chloro-5-ethoxyphenyl)boronic acid (CAS 1256345-73-9)
- methyl 2-(piperidin-4-yl)-1,3-thiazole-5-carboxylate hydrochloride (CAS 2031269-27-7)
- Semaglutide impurity 244(Fmoc-His(Fmoc)-Aib-OH) (CAS CATO-C4X-2226244)
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