Division 2.6 Solubility in water including effect of pH (4 to 10) on solubilityF1

The water solubility of purified active substances under atmospheric pressure must be determined and reported in accordance with method A 6 of Regulation (EC) No 440/2008. These water solubility determinations must be made in the neutral range (i.e. in distilled water in equilibrium with atmospheric carbon dioxide). Where the active substance is capable of forming ions, determinations must also be made in the acidic range (pH 4 to 6) and in the alkaline range (pH 8 to 10), and be reported. Where the stability of the active substance in aqueous media is such that water solubility cannot be determined, a justification based on test data must be provided.