Impurity control is an essential aspect of quality control in individual monographs of the Ph. Eur. In this module, you will learn about the Ph. Eur. policy for impurity control. It will cover all types of impurities, whether organic, inorganic (including elemental impurities), solvents or DNA-reactive impurities such as N-nitrosamines.
You will also learn about the analytical procedures used, the process of specification setting, the correct use of reference standards and how the different texts of the Ph. Eur. complement each other. In this context, the implementation of the relevant ICH guidelines and their importance for the Ph. Eur. will also be discussed.
The presentation will be followed by a live Q&A session.
Programme (subject to change):
10:00-11:00 Impurity control in the Ph. Eur.: theory and practical examples
11:00-11:30 Live Q&A Session
