Articles by Impact Analytical - Pharmaceutical Technology

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Articles by Impact Analytical

Impact Analytical


Articles
Extractables and Leachables Testing for Medical Applications
July 29, 2014

Polymer materials offer many benefits when used for packaging in medical applications. It is important however, to thoroughly assess potential leachables by designing appropriate extractables conditions. A materials based approach to facilitate the identification and quantitation of all extractables and leachables is presented.

The Importance of Possessing Good Polymer Chemistry Knowledge in Conducting Extractables/Leachables Studies
April 11, 2014

Extractables and Leachables studies are an important part of the development cycle of any new drug product. It is important that an appropriate packaging system is chosen such that the product is stable and protected from degradation. It is equally important that this packaging system does not affect the purity of the product by leaching chemicals into the product. Rigorous extractables and leachables testing can ensure the proper packaging system is chosen, and an integral part of this testing regiment includes an extensive knowledge polymer chemistry.

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