| CAS No. | 1373889-89-4 |
| Molecular Formula | C7H5Br2NO |
| Molecular Weight | 278.93 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Compared with other compounds in its class, the molecular weight of 278.93 g/mol gives Ambroxol impurity 116 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Ambroxol impurity 116 (CAS 1373889-89-4) is a certified pharmaceutical impurity reference standard with the molecular formula C7H5Br2NO and a molecular weight of 278.93 g/mol.
The molecular framework of Ambroxol impurity 116 (C7H5Br2NO) is characterized by an amide group, a hydroxyl group, an ether linkage, bromine substitution, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, 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.
CATO manufactures Ambroxol impurity 116 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
| 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.) | 1991 |
| Halogen Content | Br-containing |
| Nitrogen Atoms | 1 |