RT Journal Article SR Electronic T1 Determination of “Extractables” on Polymer Materials by Means of HPLC-MS JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 291 OP 301 VO 60 IS 5 A1 S. Fichtner A1 U. Giese A1 I. Pahl A1 O.W. Reif YR 2006 UL http://journal.pda.org/content/60/5/291.abstract AB 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.