Results for tag: "Extractables And Leachables"

The Extractables and Leachables (E&L) market is a subset of the drug discovery industry. It focuses on the identification and characterization of substances that can migrate from the packaging and delivery systems of pharmaceutical products into the drug product. This includes substances that are intentionally added to the packaging, such as preservatives, as well as substances that are unintentionally present, such as residual solvents. The goal of E&L studies is to ensure that the drug product is safe and effective for its intended use. E&L studies are conducted in accordance with regulatory guidelines, such as those from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These studies involve the use of analytical techniques such as chromatography, spectroscopy, and mass spectrometry to identify and quantify the substances present in the drug product. Companies in the E&L market include Eurofins, Intertek, SGS, and Waters Corporation. Show Less Read more