PT  - JOURNAL ARTICLE
AU  - Deluca, Paul P.
AU  - Papadimitriou, Dimitri
AU  - Deluca, Patrick P.
TI  - The Application of Proposed Procedures for Testing for Extractables in Plastic Containers
DP  - 1982 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 28--34
VI  - 36
IP  - 1
4099  - http://journal.pda.org/content/36/1/28.short
4100  - http://journal.pda.org/content/36/1/28.full
SO  - PDA J Pharm Sci Technol1982 Jan 01; 36
AB  - 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.