# Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division 2.6: Solubility in water including effect of pH (4 to 10) on solubility

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/A/division/2/division/2.6 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.