PT - JOURNAL ARTICLE AU - Jenke, Dennis AU - Zietlow, David AU - Sadain, Salma TI - Leaching of Organic Acids from Irradiated EVA Plastic as a Function of Solution pH and Polarity DP - 2004 Jan 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 24--31 VI - 58 IP - 1 4099 - http://journal.pda.org/content/58/1/24.short 4100 - http://journal.pda.org/content/58/1/24.full SO - PDA J Pharm Sci Technol2004 Jan 01; 58 AB - 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.