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Whitepaper

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

Dennis Jenke

PhD
Principal Consultant

In March 2017, Dr. Dennis Jenke became Principal Consultant for Nelson Labs Europe. In this role, Dr. Jenke supports the customers of Nelson Labs Europe in the discussion of general principles, concepts, tactics, and/or strategy related to chemical characterization and qualification of materials, components, and systems used in these industries. Furthermore, as Principal Consultant, Dr....

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