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Extractables and Leachable Testing
Packaging, storage and distribution of products are important parameters to investigate when seeking to understand the quality of your product. We can offer testing to support a company’s assessment of the packaging of drug products, medical devices and proprietary products.
ICH and USP <1663> /<1664> (draft monographs) give guidance on testing for extractables and leachable analysis, but one of the most important aspects is the extraction of the samples to be suitable for the end use of the product. Agenda1 have tested a wide variety of products using the techniques listed in the table below. An accumulation of all of these techniques is required to get a full picture of the behaviour of samples, when subjected to degradation conditions.
* followed by MS/MS, where required. † compliant with USP<232> /<233>