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The West Blog

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January 19, 2018

West Expert Addresses Extractables and Leachables at Symposium in China

Extractables and leachables (E&amp;L) pose a potential risk to patient safety. Both pharmaceutical companies and regulatory agencies have rising concerns regarding E&amp;L, which has led the <em>Center for Drug Evaluation</em> under the China Federal Drug Administration (CFDA) to release a new standard for public comment (December 30, 2016): <em>Technical Guideline for Compatibility Study of Chemicals and Elastomer Closures.</em> The compatibility study discussed therein focused on E&amp;L.
Lynn Yao

Lynn Yao

Senior Specialist, SA, CN

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