Extractables & Leachables
EAG scientists have applied extractables and leachables (E&L) testing programs to help clients confirm the safety of their products, as well as confirming material consistency and quality. The goal of an extractables and leachables study is to identify chemicals released or migrated from product under conditions of normal use. The types of materials we have experience analyzing include plastics, metals, textiles, food, packaging and personal care products. We also evaluate product stability by performing extractable and leachable testing under environmental stressed and accelerated aging conditions.
Pharma and Medical Device Guidelines
Guidelines from the pharmaceutical and medical device industries are the basis for customized studies which are customized for our client’s needs. These non-regulated investigations enable consumer product manufacturers to address consumer complaints and ensure the robustness and consistency of their products.
Relevant Services
These E&L studies may include:
- Extracting the sample using appropriate solvents
- Profiling the chemical components using analytical techniques such as GC-MS, LC-MS, ICP-MS, HPLC, GC to identify chemicals released under normal use
- Reviewing data with toxicologist
- Developing and qualifying methods to quantify any known compounds of concerns which may include irritants or sensitizers
Acting as a bridge between multiple disciplines, EAG keeps our client informed. We provide and manage data from toxicologists, statisticians and suppliers. Our scientists are skilled at presenting this data in legal testimony and consumer product safety committees, both inside and outside the US.
Typical Extractables & Leachables Techniques
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