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Research ArticleRESEARCH

Leaching of Organic Acids from Irradiated EVA Plastic as a Function of Solution pH and Polarity

Dennis Jenke, David Zietlow and Salma Sadain
PDA Journal of Pharmaceutical Science and Technology January 2004, 58 (1) 24-31;
Dennis Jenke
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David Zietlow
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Salma Sadain
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Abstract

The leaching of several target organic acids from an irradiated ethylene vinyl acetate material, such as those used as a solution product container, is examined as a function of solution pH and polarity. The targeted compounds included highly soluble weak acids such as acetic and formic acids, and larger, more lipophillic acids such as myristic, palmitic, and stearic acids. The leaching of these compounds was examined over a pH range of 3 to 11 and in various ethanol/water proportions. While pH and solution polarity had only a modest impact on the accumulation of the acetic and formic acids, the accumulation of the fatty acids was greatly affected by both factors. It is suggested that the accumulation of these leachables at high pH is influenced by two processes. The first process, partitioning, the speciation of the acidic leachables (protonated versus dissociated form) contributes to the pH trends observed. In this case, entities that already exist in the plastic partition themselves between the plastic and solution via migration. A second, more important, contributor to the leaching of these acids is a pH-dependent increase in their availability arising from an unspecified reactive process.

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PDA Journal of Pharmaceutical Science and Technology
Vol. 58, Issue 1
January/February 2004
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Leaching of Organic Acids from Irradiated EVA Plastic as a Function of Solution pH and Polarity
Dennis Jenke, David Zietlow, Salma Sadain
PDA Journal of Pharmaceutical Science and Technology Jan 2004, 58 (1) 24-31;

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Leaching of Organic Acids from Irradiated EVA Plastic as a Function of Solution pH and Polarity
Dennis Jenke, David Zietlow, Salma Sadain
PDA Journal of Pharmaceutical Science and Technology Jan 2004, 58 (1) 24-31;
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  • Development and Justification of a Risk Evaluation Matrix To Guide Chemical Testing Necessary To Select and Qualify Plastic Components Used in Production Systems for Pharmaceutical Products
  • A General Assessment of the Physiochemical Factors That Influence Leachables Accumulation in Pharmaceutical Drug Products and Related Solutions
  • Application of Quality by Design (QbD) Principles to Extractables/Leachables Assessment. Establishing a Design Space for Terminally Sterilized Aqueous Drug Products Stored in a Plastic Packaging System
  • Extraction of Stearate Salts from Plastic Materials Used in Pharmaceutical Applications
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