Impurity Testing in the European Pharmacopoeia

Ulrich Rose, European Pharmacopeia Department, EDQM, EDQM, France (ulirose57@hotmail.com)

The European Pharmacopoeia describes official standards for the quality control of pharmaceuticals which represent the obligatory standards in 39 member countries of the European Pharmacopoeia Convention. One of the core parts of individual and general monographs, but also of general chapters and texts consists of the control of different types of impurities, using a wide variety of analytical procedures enabling to detect and quantify impurities at low levels, if required.

The control of the different types of impurities, organic, inorganic, volatiles, DNA-reactive impurities as well as elemental impurities and the implementation of different ICH-guidelines are described in this presentation.