| CAS No. | CATO-C4X-1312136 |
| Molecular Formula | C9H17NO3 |
| Molecular Weight | 187.24 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The occurrence of Pregabalin Impurity 136 is closely related to an amino-acid-derived structure, an amide 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, Pregabalin Impurity 136 (CAS CATO-C4X-1312136, C9H17NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Pregabalin Impurity 136 (C9H17NO3) contains an amino-acid-derived structure, an amide 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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.
| Molecular Formula | C9H17NO3 |
| Molecular Weight | 187.24 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 2.0 |
| Nitrogen Atoms | 1 |