CAS number： 148553-50-8
Molecular formula： C8H17NO2
molecular weight： 159.229
Chemical structure：
| TEST | SPECIFICATION | Results |
| Description | White to off-white crystalline powder. | White crystalline powder |
| Solubility | Sparingly soluble in water | Sparingly soluble in water |
| Identification By IR | The infrared absorption spectrum of the substance being examined should be concordant with the infrared absorption spectrum of Pregabalin reference standard / working standard. | complies |
| Specification optical rotation [C=1 % w/v in water at 200C] | Between+10.0o to + 12.0º; on anhydrous basis. | +11.6o |
| Heavy metals | Not more then 20 ppm | Complies |
| Related substances [By HPCL] Single unspecified impurity | Not more than 0.5% | 0.23% |
| Total impurity | Not More than 1.0 % | 0.31% |
| Water content [By KF] | Not more than 0.5 % w/w | 0.18 % w/w |
| Sulphated ash | Not more than 0.1%w/w | Complies |
| Assay [By titration] | Not less than 98.0 % and not more than 102.0% on anhydrous basis. | 100.4%w/w |
