| CAS No. | 2912-98-3 |
| Molecular Formula | C8H11NO |
| Molecular Weight | 137.18 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
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 supplies Pregabalin Impurity 64 (CAS 2912-98-3), a pharmacopoeial impurity reference standard (molecular formula C8H11NO, MW 137.18 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Pregabalin Impurity 64 is typically off-white to pale yellow liquid. Its solid-state physicochemical attributes — including a molecular weight of 137.18 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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).
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 | C8H11NO |
| Molecular Weight | 137.18 g/mol |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |
| Nitrogen Atoms | 1 |