Bromhexine impurity 55 CAS CATO-C4X-106055
| CAS No. | CATO-C4X-106055 |
| Molecular Formula | C15H20Br2N3O |
| Molecular Weight | 418.15 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Bromhexine impurity 55 (CAS CATO-C4X-106055, C15H20Br2N3O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Bromhexine impurity 55 (C15H20Br2N3O) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, bromine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C15H20Br2N3O |
| Molecular Weight | 418.15 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at room temperature, 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) | 6.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Br-containing |
| Nitrogen Atoms | 3 |
Related Bromhexine Standards
- Bromhexine Impurity 18 (CAS CATO-C4X-106018)
- Bromhexine Impurity 47 (CAS CATO-C4X-106047)
- Bromhexine impurity 54 (CAS CATO-C4X-106054)
- Bromhexine Impurity 15 (CAS 2724689-57-8)
- Bromhexine Impurity 44 (CAS CATO-C4X-106044)
- Bromhexine Impurity 20 (CAS CATO-C4X-106020)
- Bromhexine Impurity 46 (CAS 3472-84-2)
- Bromhexine Impurity 10 (CAS 2512203-87-9)
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