E&Ls can enter a drug product during manufacturing, storage, and from the packaging system.

The packaging components (those in contact with the drug product) can contain organic and inorganic E&L contaminants present a risk due to their inherent toxicity, while other compounds may adversely affect the efficacy, stability, and shelf-life of the drug.

We will share an E&L study that shows both the potential for the drug product to become contaminated under extreme conditions (extractables), and the actual contamination that occurs during normal and extended storage (leachables).