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.
Footnotes
- Copyright © Parenteral Drug Association. All rights reserved.
PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.
If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing.
Full issue PDFs are for PDA members only.
Note to pda.org users
The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.