The safety of pharmaceuticals, foodstuffs and cosmetics may be compromised by chemical compounds in the food contact materials (FCMs) and other packaging that is in direct contact with the consumer product. 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) - Impurities and reaction and breakdown products from starting substances used to produce food contact plastics.
Due to continuously increasing global regulations, the characterization of packaging and FCMs has become more critical than ever for the manufacturers that supply the pharmaceutical, food and cosmetics industries. To ensure regulatory compliance, avoid product recalls and protect their brands, these organizations must carefully control and monitor their products to eliminate the potential risks associated with extractable, leachable and NIAS compounds.
Untargeted screening of complex matrices in E&L analysis can be a laborious and time-consuming process, with any number of components requiring identification with a certain level of confidence, and this is only becoming more prevalent with the introduction of new regulations and the tightening of existing regulations, directing E&L analysis in everything from the medical device industry to plastics for food packaging.
A tailor-made E&L library has been carefully and continuously curated by Waters and our E&L partner, Merck, to ensure the both highest quality and relevance for the application, the library offers analysts information on product ions, retention time, and collision cross section values, to improve analyst confidence in the identification of unknowns. The Extractables and Leachables HRMS library can be downloaded from Waters Marketplace under UNIFI - Scientific Libraries upon registration.
Waters provides a wide range of technologies including Atmospheric Pressure GC, time-of-flight mass spectrometry, convergence chromatography, and supercritical fluid extraction, that enable accurate, rapid and cost effective identification of extractable, leachable and NIAS contaminants.
Featured Application Notes:
View All
Featured Video:
In this SelectScience video interview, Cristina Nerin of the University of Zaragoza discusses her work on analyzing food packaging materials.
