purity tests shall be described in relation to the sum total of predictable impurities, especially those which may have a harmful effect, and, if necessary, those which, having regard to the combination of substances to which the application refers, might adversely affect the stability of the medicinal product or distort analytical results;
preskusi čistote se morajo opisati glede na celotno količino predvidenih nečistot, posebno tistih, ki bi lahko imele škodljiv učinek in, če je to potrebno, tistih, ki bi v kombinaciji snovi, na katero se vloga nanaša, lahko imele neželen učinke na stabilnost zdravila, ali bi lahko popačile analitske rezultate;