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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Waters Corporation, headquartered in Milford, Massachusetts, USA, has played a pioneering role as a specialized manufacturer of liquid chromatography since its establishment in 1958. Actively engaged in the development of new products and technologies, it has grown into an international group company that supplies not only high-performance liquid chromatography but also mass spectrometers (MS) and thermal analysis instruments. Waters Japan started operations in 1973 (Showa 48) as the Japanese base of Waters Corporation. Inheriting the corporate ethos of the U.S. headquarters, we have made "Customer Success" our mission and continue to provide innovative technologies and lab solutions.