This article from Issue 10 of the Analytix Reporter, produced by Merck, introduces a series of new reference materials for E&L testing, including a toxic degradation product of Irganox 1010.
Extractables and leachables (E&L) are chemical substances that can potentially migrate from polymers of packaging materials, tubings or medical devices into a pharmaceutical product and affect safety and quality of a product. That’s why extensive extractables and leachables studies are required from manufacturers to show that their products cannot expose patients to harmful amounts of such chemicals. Extractables and leachables are also relevant in Food Safety testing,
where they are covered by Food Contact Materials regulations.
To facilitate identification and quantification of extractables and leachables, Merck offers a comprehensive portfolio of reference materials. A list of more than 100 certified reference materials and analytical standards for commonly found extractables and leachables can be found on at SigmaAldrich.com/extractablesandleachables
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*The life science business of Merck operates as MilliporeSigma in the U.S. and Canada.