Chemical Leaching of Rubber Stoppers into Parenteral Solutions

A determination was made of various chemical compounds leached from rubber stoppers into large volume parenteral solutions. Two kinds of rubber stoppers and 12 lots of large volume parenteral solutions with the same types of stoppers were evaluated. With the exception of furfural, the same chemical compounds were extracted from the parenteral solutions and from unused stoppers. Results showed that many chemical compounds are leached from rubber stoppers into large volume parenteral solutions and that some can cause harmful effects at certain concentration levels. Quantitative testing is needed to determine the levels of leached chemicals present in parenteral solutions.