[Replacement of the pyrogen-test as batch control test for the biological substances aprotinin and urokinase] [Article in German]

Abstract

In the Pharmeuropa Vol. 10, No. 4, December 1998, the European Pharmacopoeia Commission published an appeal to replace the pyrogen test by the limulus test for a total of 10 biological substances. These substances included the active ingredients aprotinin and urokinase, contained in our sales products AntagosanÒ and ActosolvÒ. After successful validation of the limulus test, we calculated endotoxin limit concentrations for these and submitted these to the European Department for Quality of Medicines (EDQM). We expect - not least on the basis of the data submitted by ourselves - that the pyrogen test will be replaced in future as a quality control test by the limulus test in testing aprotinin and urokinase compounds for the presence of pyrogenic substances. This leads to a reduction in the number of rabbits used as opposed to the current pyrogen test for testing the stated compounds.