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Whitepaper

WHITEPAPER

Establishing the Proper Alcohol/Water Proportion for Simulating Solvents Used in Controlled Extraction Studies

The purpose of this paper is to provide guidance on determining the proper alcohol/water proportion for simulating solvents used in controlled extraction studies relevant to drug products that are packaged in plastic container systems, administered via plastic devices or manufactured using systems that consist of plastic components.

This paper provides scientific guidance as well as a case study on the effect of solvent polarity (Ethanol/water proportion) on the levels of Extractables.

Dennis Jenke, PhD

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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