RS)-2-(2-oxo-4-phenylpyrrolidin-1-yl)acetamide compound having modulatory activity with a commensurate effect, pharmaceutical substance (variants) and its application, composition (variants) thereof

Use of the pharmaceutical substance (RS)-2-(2-oxo-4-phenylpyrrolidin-1-yl)acetamide in the manufacture of any expedient pharmaceutical or para-pharmaceutical composition that has an activity acceptable for its intended purpose as in any one of claims 1 to 40, differing in that before the start of standard industrial production of the composition, the substance powder is sieved through a sieve and dried to a constant weight, characterized by the following indicators:

• 2-(2-oxo-4-phenylpyrrolidin-1-yl)acetamide—not less than 99.0% and not more than 100.5% on dry basis;
• individual related impurities (precursors and products of synthesis) individually or in total—not more than 0.2%;
• residual amounts of organic solvents individually or in total—not more than 0.3% (not more than 3000 ppm);
• sulphate ash—not more than 0.1%, heavy metals—not more than 0.001%, loss on drying—not more than 0.1%, the melting point 130 to 133° C.

Titrimetric assay method of 2-(2-oxo-4-phenylpyrrolidin-1-yl)acetamide which consists in following:

• 0.2 g (accurately weighed) of powder substance of (RS)-2-(2-oxo-4-phenylpyrrolidin-1-yl)acetamide was placed in a Kjeldahl flask;
• 20 ml of 0.1 M hydrochloric acid solution was added, the Kjeldahl flask was attached to the apparatus for determination of nitrogen and the distillation was started;
• after having obtained the steady distillation, 40 ml of 30% sodium hydroxide was slowly added to the flask (making sure that the solution in the flask was stirred by the steam flow), 200 mL of distillate were collected in the receptacle with 20 ml of 4% boric acid solution and 0.1 ml of mixed indicator solution;
• the distilled fraction was titrated with 0.1 M hydrochloric acid to achieve the red-violet color, and the control experiment was carried out (1 ml of 0.1 M solution of HCl corresponds to 0.021826 g or 21.826/21.83 mg of C12H14N2O2).