Edit the instructions. Trisol, solution for infusions, regarding methods of quantitative determination and norms for the content of active substances

May 23, 2016
ICD-10:
XX.Y40-Y59.Y54.6    Drugs affecting the electrolyte, energy and water balance
Trisol, electrolytes, water-electrolyte balance, dehydration, intoxication

When conducting an examination of the quality of the medicinal product "Trisol,solution for infusions "revealed the need to refine the regulatory documentation in terms of quantification methods and standards for the content of active substances.

Calculation of the sodium and potassium content of chlorides using the equivalent amount of substances is incorrect. The technique described in the normative documentation allows to estimate the total content of chloride ions.

Considering the salt composition of the medicinal preparation Trisol, solution for infusions, it is necessary to add the ionic composition in the "Composition" section, and to provide a quantitative determination for the ions included in the preparation (chloride, hydrogen carbonate, sodium and potassium ions).