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Latest Post

December 05, 2018

Why Every Extractables Study Should Be Tailor-Made

In determining extractables from parenteral drug packaging systems, the FDA is clearly looking for appropriate choices of solvents, times, temperatures and other conditions that could impact the results of studies. The outcome of the studies should support the intended purpose – to allow for practical correlations and design of leachables studies.
Bettine Boltres

Bettine Blotres Ph.D.

Manager, Technical Account, TCS

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West’s Extractables Data Guide    (West EDGe)

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Erica Tullo, Ph.D.

Manager, Extractables & Leachables Technology

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