What's the difference between Extractables and Leachables - HPLC Primer
Date: 12-OCTOBER-2023 Last Updated: 26-OCTOBER-2025
Extractables and Leachables are both chemical species that migrate from packaging or container materials into the sample or other contents, but the difference is the conditions under how they are acquired.
Extractables: These are compounds that can be extracted from a packaging component, delivery system, or manufacturing surfaces via laboratory manipulation, such as exposure to solvents or heat. Extractables are obtained under exaggerated or forcing conditions using solvents or simulation media. This provides an effective worst-case scenario in terms of what can migrate from a component.
Leachables: These are compounds that leach from a container / closure system into the finished drug products under normal storage conditions. Leachables are obtained under normal application or storage conditions. They are generally a subset of the extractables, although interaction with product components may produce leachables not seen as extractables.
In short: extractable studies are designed to obtain a fingerprint of chemical components that can be extracted under exaggerated conditions, while leachable studies aim to identify what compounds might migrate into the product under normal conditions.
If the manufacturer has changed their resin or mold release agents, it could potentially introduce new leachables or contaminants. Therefore, it’s important to conduct an E&L study to confirm if any new leachables or contaminants have been introduced.
Extractables and Leachables are both chemical species that migrate from packaging or container materials into the sample or other contents, but the difference is the conditions under how they are acquired.
Extractables: These are compounds that can be extracted from a packaging component, delivery system, or manufacturing surfaces via laboratory manipulation, such as exposure to solvents or heat. Extractables are obtained under exaggerated or forcing conditions using solvents or simulation media. This provides an effective worst-case scenario in terms of what can migrate from a component.
Leachables: These are compounds that leach from a container / closure system into the finished drug products under normal storage conditions. Leachables are obtained under normal application or storage conditions. They are generally a subset of the extractables, although interaction with product components may produce leachables not seen as extractables.
In short: extractable studies are designed to obtain a fingerprint of chemical components that can be extracted under exaggerated conditions, while leachable studies aim to identify what compounds might migrate into the product under normal conditions.
If the manufacturer has changed their resin or mold release agents, it could potentially introduce new leachables or contaminants. Therefore, it’s important to conduct an E&L study to confirm if any new leachables or contaminants have been introduced.