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Leachable & Extractable Analysis

The study of leachables and extractables helps to assure that products we use every day are safe and free of undesired contaminants. Studies of extractables performed on processing and production materials and on product containers and closures help to identify the potential substances that can leach into a product during production or storage over its shelf life.  Examination of a process or a product stored over time for the presence of any of these contaminants discovered during studies of extractables  determines the true leachable materials.

It is important to understand both the identity and nature of the extractable and leachable components to assure that a product will be free of potentially dangerous contamination.

Workflow Overview for Leachables & Extractables

Analysis of contact surfaces, such as the container and closure systems for extractables, is typically performed by extraction with solvent systems under aggressive conditions such as elevated temperature, long durations, or extreme pH values. The goal is to provide a sample that contains all components that could possibly leach into a stored product.  Extracted samples are analyzed by multiple techniques, in which mass spectrometry is the most prevalent.  The detection and subsequent identification of all potential leachable components is enabled by a complete understanding of the extractable components.  Mass spectrometers powered by Orbitrap™ technology make such complex analysis possible with high resolution (up to 240,000 FWHM at m/z 400) and robust mass accuracy.