Division 1.9 Specification of purity of the active substance in g/kgF1

The minimum content in g/kg of pure active substance (excluding inactive isomers) in the manufactured material used for production of formulated products, must be reported.

Where the information provided relates to a pilot plant production system, the information required must again be provided to F2each competent authority which granted approval once industrial scale production methods and procedures have stabilised, if production changes result in a changed specification of purity.