The Application of Proposed Procedures for Testing for Extractables in Plastic Containers

Abstract

An aqueous extraction procedure for testing plastic containers has been proposed which calls for studying the containers in the actual vehicle system without drug, but buffered at the pH of the drug-containing solution. This test which can be used both for the selection process for the containers and as an incoming control procedure should be preceded by rigorous solvent and aqueous extraction techniques during initial screening of the container. In the testing of a polyolefin container, the initial screening process employed chloroform and aqueous extractions of resin materials and bottle cuttings. Only from the bottle cuttings subjected to aqueous autoclaved conditions was a minor leachable detected by thin-layer chromatography. The aqueous extraction of buffered intravenous solutions revealed a single leachable which could be directly traced to the plastic container. Subsequent identification using UV, mass spectroscopy, and IR methods suggested the contaminant to be a type of aromatic ester. Knowledge of this information allowed corrective measures to be taken.