Fresenius Kabi, USA
Title: Extractable and leachable studies of parenteral infusion and transfusion products
Jianfeng Hong is a Senior Research Scientist and the Manager of the Analytical Chemistry laboratory at Lake Zurich, Illinois of Fresenius Kabi USA LLC. His major responsibilities include leading a group of analytical chemists to perform extractable and leachable testings, as parts of biocompatibility studies for material characterizations, for transfusion and infusion products of blood and pharmaceuticals of Fresenius Kabi. His group uses a wide variety of advanced analytical instrumentation including GC/ MS, UPLC/UV, Q-TOF mass spectrometer with accurate mass capability, ICP and TOC. He has over eighteen year experience as an analytical chemist with pharmaceutical and medical device industries. He earned a Master’s degree in Analytical Chemistry from University of Louisville, Kentucky, USA.
This presentation will describe the general extractable/ leachable study practices of parenteral infusion and transfusion products. It will include (1) extractable and leachable study designs and extractable/leachable study work flows using a wide variety of analytical techniques (UPLC/UV/MS, GC/MS, ICP and TOC). (2) The determinations of concentration thresholds for extractable and leachable that require identification and quantification (3) risk assessments of the extractable and leachable compounds and (4). Selection and analytical method development/validation is carried out for target leachable compounds that are monitored for the stability evaluation of infusion and transfusion products.
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