The Use and Utility of General Chemistry Data in Extractables Assessment
This whitepaper explores the critical role of general chemistry data obtained in controlled extraction studies, including pH,...
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Use of Accelerated Conditions in Extractables and/or Leachables Studies
The purpose of this whitepaper is to delve into the scientific principles behind establishing accelerated contact conditions...
Use of Exaggerated Surface Area to Solution Volume Ratios in Extractables Studies; Equilibrium Case
The goal of this whitepaper is to provide comprehensive guidance and justify appropriate practices concerning the proper...
Why Extractables and Leachables Matter
Medicines and other healthcare products rely on a delicate balance between quality, safety, and efficacy for their...
