Ambroxol Maillard Lactose Impurity 8(Ambroxol Impurity 77) CAS CATO-C4X-108577
| CAS No. | CATO-C4X-108577 |
| Molecular Formula | C18H26Br2N2O5 |
| Molecular Weight | 510.22 g/mol |
| 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.
CATO supplies Ambroxol Maillard Lactose Impurity 8(Ambroxol Impurity 77) (CAS CATO-C4X-108577), a pharmacopoeial impurity reference standard (molecular formula C18H26Br2N2O5, MW 510.22 g/mol) used for the identification and quantification of trace impurities in APIs.
Based on its molecular formula C18H26Br2N2O5, Ambroxol Maillard Lactose Impurity 8(Ambroxol Impurity 77) 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 510.22 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.
Physical & Chemical Properties
| Molecular Formula | C18H26Br2N2O5 |
| Molecular Weight | 510.22 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >90% |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Br-containing |
| Nitrogen Atoms | 2 |
Related Ambroxol Standards
- Ambroxol Maillard Lactose Impurity 1(Ambroxol Impurity 70) (CAS CATO-C4X-108570)
- Ambroxol Maillard Lactose Impurity 2(Ambroxol Impurity 71) (CAS CATO-C4X-108571)
- Ambroxol Maillard Lactose Impurity 3(Ambroxol Impurity 72) (CAS CATO-C4X-108572)
- Ambroxol Maillard Lactose Impurity 4(Ambroxol Impurity 73) (CAS CATO-C4X-108573)
- Ambroxol Maillard Lactose Impurity 7(Ambroxol Impurity 76) (CAS CATO-C4X-108576)
- Ambroxol Impurity 41 (CAS CATO-C4X-108541)
- Ambroxol Sorbide Impurity 3(Ambroxol Impurity 79) (CAS CATO-C4X-108579)
- Ambroxol Impurity 95 (CAS CATO-C4X-108595)
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