An Introduction to Extractables and Leachables Studies

Extractables and leachables (E/L) studies help to identify, quantify and minimize harmful impurities which could leach from pharmaceutical container closure systems and packaging into pharmaceutical products. A profile of extractable components must be obtained in order to identify potential sources of leachables such as antioxidants, plasticizers, dyes and metal catalysts. As pharmaceutical packaging can be extremely complex, with mixtures of plastic, polymer, rubber or glass materials, printed surfaces and coatings all used, it is critical that E/L studies are designed specifically for your drug product and the container materials. This webinar is an introduction to the topic for scientists who have a general awareness of what is involved in an extractables /leachables study but would like to know more.

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