Extractables Testing of Aluminosilicate and Borosilicate Glass Containers
When it comes to required extraction studies for new glass compositions that are starting to enter the parenteral packaging market, manufacturers naturally have questions about the suitability of these new products. One extraction study potentially answers these questions.
Extraction studies are necessary because glass containers, which are frequently considered inert, react with aqueous solutions at relatively low rates in most parenteral drug applications.
Extraction methods for glass assess the durability of the container surface to any number of solution chemistries, often accelerated using elevated temperatures. Solution analysis then quantifies the amount of glass constituents that have reacted or dissolved from the container into solution.