Jianfeng Hong
Fresenius Kabi, USA
Title: Extractable and Leachable Studies of Parenteral Infusion and Transfusion Products
Biography
Biography: Jianfeng Hong
Abstract
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 for target leachable compounds that are monitored for the stability evaluation of infusion and transfusion products.