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Whitepapers

Focus on Detecting Extractables and Leachables in Drug Products to Improve Patient Safety and Avoid Costly Product-launch Delays

Well-documented incidents of contaminants leaching from containers and packaging has brought heightened awareness of the health risks posed by extractables and leachables in the manufacture of pharmaceutical container systems and product packaging. In fact, the U.S. FDA and the EMEA are now placing increased scrutiny on potential extractables and leachables in drug product container and closure systems.