Ambroxol impurity 109 CAS CATO-C4X-1085109
| CAS No. | CATO-C4X-1085109 |
| Molecular Formula | C13H18BrClN2O |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Ambroxol impurity 109 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.
CATO supplies Ambroxol impurity 109 (CAS CATO-C4X-1085109), a pharmacopoeial impurity reference standard (molecular formula C13H18BrClN2OHCl, MW 370.11 g/mol) used for the identification and quantification of trace impurities in APIs.
Based on its molecular formula C13H18BrClN2OHCl, Ambroxol impurity 109 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine/bromine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 370.11 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.
Physical & Chemical Properties
| Molecular Formula | C13H18BrClN2O HCl |
| Molecular Weight | 370.11 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl/Br-containing |
| Nitrogen Atoms | 2 |
Related Ambroxol Standards
- Ambroxol Impurity 28 (Ambroxol Monobromo) (CAS 101900-43-0)
- Ambroxol Impurity 33 HCl (CAS 101900-44-1)
- Ambroxol impurity 61 (CAS 104670-74-8)
- Ambroxol impurity 68 (CAS 105735-86-2)
- Ambroxol EP Impurity D (CAS 107814-37-9)
- Ambroxol D5DISCONTINUED, offer A575902 (CAS 1246818-80-3)
- Ambroxol impurity 113 (CAS 131417-90-8)
- Ambroxol impurity 116 (CAS 1373889-89-4)
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