Study of Extractables in High-Density Polyethylene Packaging: Evaluation of the Impact of Excipients Propylene Glycol, Mint Flavor, and Benzalkonium Chloride on the Leaching Process of Semi-volatile Additives

Study of Extractables in High-Density Polyethylene Packaging: Evaluation of the Impact of Excipients Propylene Glycol, Mint Flavor, and Benzalkonium Chloride on the Leaching Process of Semi-volatile Additives

Abstract The study of extractables and leachables has become increasingly important in the pharmaceutical industry, with growing concerns about minimizing impurity risks in final products. Polymeric materials are widely used in pharmaceutical packaging due to their many advantages, but they can also introduce impurities. These materials often contain low molecular mass additives that may migrate into the product during storage and shelf life. Th…