Extractables and Leachables testing

Packaging, storage and distribution of products are important parameters to investigate when trying to understand the quality of a 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 leachables analysis, but one of the most important aspects is the extraction of the samples to be suitable for the end use of the product.

Our scientists have tested a wide variety of products using ICP-OES, LC-UV/MS, LC-CAD and GC-MS. An accumulation of all of these techniques is required to get a full picture of the behaviour of samples, when subjected to degradation conditions.