Ambroxol Impurity 31 CAS 42460-62-8
| CAS No. | 42460-62-8 |
| Molecular Formula | C7H5Br2NO |
| Molecular Weight | 278.93 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Ambroxol Impurity 31 is closely related to an amide group, a hydroxyl group, an ether linkage, bromine substitution, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Ambroxol Impurity 31 (CAS 42460-62-8, C7H5Br2NO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to an amide group, a hydroxyl group, an ether linkage, bromine substitution, an aromatic ring system, Ambroxol Impurity 31 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 278.93 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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), Ambroxol Impurity 31 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.
Physical & Chemical Properties
| Molecular Formula | C7H5Br2NO |
| Molecular Weight | 278.93 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1969 |
| Halogen Content | Br-containing |
| Nitrogen Atoms | 1 |
Related Ambroxol Standards
- Ambroxol impurity 116 (CAS 1373889-89-4)
- Ambroxol Impurity 49 (CAS 86379-71-7)
- Ambroxol EP Impurity A (CAS 50739-76-9)
- Ambroxol Impurity 20 (CAS 609-85-8)
- Ambroxol Impurity 37 (CAS CATO-C4X-108537)
- Ambroxol Impurity 83 (CAS CATO-C4X-108583)
- Ambroxol Impurity 28 (Ambroxol Monobromo) (CAS 101900-43-0)
- Ambroxol Impurity 85 (CAS CATO-C4X-108585)
Recommended Standards
- ,2-dichloro-4-iodo-benzen;Benzene,1,2-dichloro-4-iodo-;3,4-Dichloro-1-iodobenzene 20555-91-3 3,4-Dichloroiodobenzene A20568 (CAS 20555-91-3)
- Bromhexine EP Impurity B (CAS 50910-55-9)
- 3032-81-3 Benzene, 1,3-dichloro-5-iodo- 1,3-Dichloro-5-iodobenzene 3,5-Dichloroiodobenzene 3,5-Dichlorophenyl iodide EINECS 221-216-3 NSC 80149 (CAS 3032-81-3)
- 4,6-Dibromopicolinimidamide (CAS 2089327-49-9)
- Doxofylline Impurity 33 (CAS CATO-C4X-151333)
- Procaterol Impurity 27 (CAS CATO-C4X-181027)
- Fenofibrate EP Impurity E (CAS 42019-07-8)
- {[1-(2-ethoxyphenyl)-1H-tetrazol-5-yl]thio}acetic acid (CAS 436095-22-6)
- (4R,5S)-4-Ethyl-5-(hydroxymethyl)pyrrolidin-2-one (CAS 1817630-28-6)
- 1-Chloro-4-(2-methoxyethoxy)-2-nitrobenzene (CAS 1870242-16-2)
- N-(3-Cyano-4,5-dimethylthiophen-2-yl)-3,4-difluorobenzamide (CAS 1043320-52-0)
- 5-Hydroxy-2-methoxybenzamide (CAS 180526-91-4)
- Mianserin impurity 54 (CAS CATO-C4X-136954)
- Semaglutide Impurity 129 (CAS 2490269-79-7)
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