Sodium Fusidate Impurity 18 CAS 16391-75-6
| CAS No. | 16391-75-6 |
| Molecular Formula | C31H48O6 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The molecular framework of Sodium Fusidate Impurity 18 (C31H48O6C4H11NO2) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. 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 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).
As a process- or degradation-related impurity, Sodium Fusidate Impurity 18 (CAS 16391-75-6, C31H48O6C4H11NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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), Sodium Fusidate Impurity 18 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 | C31H48O6 C4H11NO2 |
| Molecular Weight | 621.86 g/mol |
| Purity | >95% |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1961 |
| Nitrogen Atoms | 1 |
Related Sodium Standards
- Sodium Fusidate EP Impurity M (CAS 1013937-16-0)
- Sodium Fusidate EP Impurity J (CAS 13011-12-6)
- Sodium Fusidate EP Impurity O (CAS 13090-91-0)
- Sodium Fusidate EP Impurity F (CAS 1415035-94-7)
- Sodium Fusidate EP Impurity H (CAS 16711-91-4)
- Sodium Fusidate EP Impurity G (CAS 4680-37-9)
- Sodium Fusidate EP Impurity K (CAS 4701-54-6)
- Sodium Fusidate EP Impurity O Sodium Salt (CAS 55601-53-1)
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