Infographic: Simplifying the Screening Workflow for Extractables Testing

By February 2, 2017

How to design an analytical workflow to screen for extractables and leachables

The safety of pharmaceuticals, cosmetics, and foodstuffs may be compromised by chemical compounds in the various types of packaging and food contact materials (FCMs) that are in direct contact with the consumer product.

Due to continuously increasing global regulations, the characterization of extractables and leachables from packaging and FCMs has become more critical than ever for the manufacturers that supply the pharmaceutical, food, and cosmetics industries.

These chemical compounds are typically categorized as:

  • Extractables – compounds which are extracted from packaging or device components under controlled extraction conditions.
  • Leachables – compounds which migrate from the packaging into the product during its normal shelf life.
  • Non-intentionally added substances (NIAS) – degradation products from FCMs, impurities of starting materials, and contaminants from recycling processes.

For characterizing extractables in packaging, the initial step includes targeted screening, i.e., testing the extracts for known compounds. This is a well-established process and can be performed in various ways by using analytical techniques ranging from GC-FID-MS to LC-UV-MS.

However, the final packaging may have impurities present from starting materials and additional degradants such as those formed during the molding process. The structural elucidation of unknowns is typically a very complex and time-consuming process that requires the analyst to have a high level of expertise.

Waters UNIFI Scientific Information System provides a simple workflow for use with high-resolution mass spectrometry analysis, including ion mobility MS, that can streamline the structural elucidation process. UNIFI software features include scientific library creation, multivariate statistical analysis, elucidation, and reporting. By integrating the analytical platform with application-specific informatics, we’re enabling analysts to evaluate complex data in a more efficient way by simplifying data review, which can facilitate the decision-making process. Take a look at how we do it.


Extractablese and leachables in drugs and packaging | Infographic


Download our technical note that with details about this extractables testing screening workflow, featuring:

  • A simple MS methodology using high-resolution mass spectrometry (HRMS) that can be adopted for cosmetics, 3D printing media, food, and pharmaceutical packaging extractable applications.
  • A workflow that streamlines the structural elucidation process for packaging extracts by utilizing MSE data of accurate mass precursor and fragment ion information on a single software platform
  • A rapid and automated way to evaluate information for an unknown component (m/z) by ranking the possible elemental compositions, and searching databases for likely structures ranked based on fragmentation matching.

Waters provides a wide range of technologies including Convergence Chromatography, Supercritical Fluid Extraction, Atmospheric Pressure GC, and Time-of-Flight Mass Spectrometry that enable accurate, rapid, and cost effective identification of extractable, leachable, and NIAS contaminants.

Organizations in the food supply chain, pharmaceutical manufacturers, and other brands such as cosmetics companies can rely on Waters’ deep analytical knowledge of how to apply purposefully designed technologies to control and monitor their products, to eliminate the potential risks associated with extractable, leachable, and NIAS compounds, and thus to ensure regulatory compliance, avoid product recalls and protect their brands.

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