Determination of “Extractables” on Polymer Materials by Means of HPLC-MS

Abstract

In biopharmaceutical processes, in the area of food and medical technology a variety of devices is used. These devices consist of various polymers. The detection and identification of potential extractables from these polymers during application are requested by the regulatory bodies. For risk and toxicity assessment, both identification and quantification of extractables are necessary. This article describes the development of a LS—MS methodology transfered from an established HPLC—UV—VIS method for full extractables analysis of sterile-grade filtration cartridges.