Tino Otte, Senior Scientific Consultant at Intertek, is an expert for analysis of impurities and contaminations in pharmaceutical products.
He holds a degree in polymer-chemistry from the University of Halle/Saale and a Ph.D. from the Darmstadt Technical University, where he graduated in 2010.
He joined Intertek (Schweiz AG) in 2016. Prior to joining Intertek, he worked with different research, development and manufacturing companies where he served in several functions in product management and development of analytical services.
He has more than 7 years of experience in GMP regulated environment within multiple areas of product analysis including method development, validation and QC.
Silicone quantification by q-NMR is presented as a more sensitive and faster method compared to traditional techniques. Advantages such as the simplified sample preparation, reduced sample quantity and less matrix influence will be highlighted. The application range of the method and the general procedure are explained in detail and case studies are shown. Content:
For patient safety reasons a precise knowledge about potential drug impurities is essential. With increasing complexity of container closure systems and single use process equipment the risk of leachables being introduced as real drug impurities increases significantly. Authorities are extensively focusing on determination of leachables present in the real drug matrix which increases the analytical effort and complicates data interpretation.
According to general guidelines the E&L studies are commonly divided into different parts:
During this presentation we will focus on the problems which may occur when extractables or leachables above the analytical evaluation threshold are detected during the different steps. Several case studies will be presented. Content: