‘impurity’ means any component other than the pure active substance and/or variant which is present in the technical material (including components originating from the manufacturing process or from degradation during storage).
„nečistoče“ so kakršne koli druge sestavine, ki niso čista aktivna snov in/ali varianta in ki jih vsebuje tehnični material (vključno s sestavinami, ki nastanejo med proizvodnim postopkom ali so posledica razgrajevanja med skladiščenjem).