Quantitative Determination of Chemicals Leached from Rubbert Stoppers into Parenteral Solutions

Amounts of some chemical compounds leached from rubber stoppers into large volume parenteral solutions have been determined using gas chromatography. The results, given in micrograms per bottle, show that there are differences in the quantities of stopper components in products of the same lot number, in various products, and in different bottle sizes. The quantitative determination of identified components leached from rubber stoppers provides a means for evaluating the health risks of the extractables.