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Gyorgy Vas

Articles

Extractable and Leachable Testing for Pharmaceutical Packaging, Finished Pharmaceutical Products, and Medical Devices: An Analytical Perspective

July 01, 2020

Extractable and leachable (E&L) testing for finished pharmaceutical products, bioprocess manufacturing systems, and medical devices is currently a subject of intense interest. The majority of the challenges encountered in analytical workflows are related to the highly complex matrices and relatively low analyte evaluation thresholds seen in E&L studies. This paper provide options for executing E&L testing to supporting regulatory submissions. There are multiple compliant routes possible, and the presented workflows and analytical solutions are only one of multiple successful approaches.

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