Extractables/Leachables Solution
Accurate, rapid, and cost-effective identification of compounds.
Extractables and leachables from polymers, monomers, and additives in plastics used in pharmaceutical packaging and single-use systems for biopharmaceuticals must be managed in terms of drug safety and quality. However, the analysis and evaluation of extractables/leachables from plastic products supplied by suppliers often lack clarity regarding the components, presenting numerous challenges. The wide range of technologies offered by Waters can accurately and cost-effectively identify extractables and leachables in a short period.
basic information
The safety of pharmaceuticals, cosmetics, and food can be compromised by compounds found in various types of packaging and food contact materials (FCM) that come into direct contact with consumer products. To comply with regulations, avoid product recalls, and protect their brand, manufacturers need to carefully control and monitor their products to eliminate potential risks associated with extractables/leachables and unintentionally introduced compounds. Waters provides a wide range of technologies, including UPC2, SFE, APGC, and time-of-flight mass spectrometry, to accurately, quickly, and cost-effectively identify extractables/leachables and unintentionally introduced compounds.
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Applications/Examples of results
For more details, please contact us or download the application note.
