Topiramate Impurity 25 CAS 25018-67-1
| CAS No. | 25018-67-1 |
| Molecular Formula | C12H20O6 |
| Molecular Weight | 260.28 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Topiramate Impurity 25 (CAS 25018-67-1) is a certified pharmaceutical impurity reference standard with the molecular formula C12H20O6 and a molecular weight of 260.28 g/mol.
Topiramate Impurity 25 (C12H20O6) contains 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.
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 | C12H20O6 |
| Molecular Weight | 260.28 g/mol |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 3.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 1964 |
Related Topiramate Standards
- Topiramate Impurity 24 (CAS 582-52-5)
- Topiramate Impurity 40 (CAS CATO-C4X-176840)
- Topiramate EP Impurity A (CAS 20880-92-6)
- Topiramate Impurity 15 (CAS 128316-82-5)
- Topiramate Didesacetal Impurity (CAS 106881-42-9)
- Topiramate Impurity 12 (CAS CATO-C4X-176812)
- Topiramate Impurity 1 (CAS 32785-90-3)
- Topiramate Impurity 13 (CAS 86569-78-0)
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