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PQRI Establishes Thresholds for L&E Identification

Findings Presented at March PQRI Meeting

Members of the Product Quality Research Institute (PQRI) Parenterals and Ophthalmic Drug Products (PODP) Working Group presented the results of their eight-year, multistudy effort to establish threshold limits for the identification of leachables and extractables (L&E) at the 3rd PQRI/FDA Conference on Advancing Product Quality in Rockville, Md., March 22–23.