Gentamicin Impurity 28 CAS 51846-97-0
| CAS No. | 51846-97-0 |
| Molecular Formula | C19H39N5O9 |
| Molecular Weight | 481.54 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Gentamicin Impurity 28 is closely related to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Gentamicin Impurity 28 (CAS 51846-97-0, C19H39N5O9) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Gentamicin Impurity 28 (C19H39N5O9) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.
As a certified reference material (CRM), Gentamicin Impurity 28 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 | C19H39N5O9 |
| Molecular Weight | 481.54 g/mol |
| Appearance | White to pale yellow crystalline powder |
| Purity | 97%+ |
| 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 |
| Degree of Unsaturation (DBE) | 3.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 1971 |
| Nitrogen Atoms | 5 |
Related Gentamicin Standards
Recommended Standards
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