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WHITEPAPER

Use of Accelerated Conditions in Extractables and/or Leachables Studies

The purpose of this paper is to consider the scientific basis for accelerated contact conditions (via the proper combination of contact temperature and duration) for studies which involve the migration of substances (either extractables or leachables) from plastics and into contact solution (such as extraction solvent or drug products).

Considering this scientific basis, recommendations concerning proper acceleration strategies are provided.

Dennis Jenke, PhD

Dennis Jenke, PhD

Principal Consultant

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