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. https://pharmaceutical.report/Resources/Whitepapers/648cce6f-6702-44bb-a14b-473516cf102f_White_Paper_Analysis_of_Extractable.pdf
whitepaper
SHARESHARESHARE
ANALYSIS OF EXTRACTABLES AND LEACHABLES
Manufacturers of pharmaceuticals, drug delivery systems, and biomedical devices have come under growing pressure to perform sensitive and accurate analytical studies to detect, identify, and quantify extractable and leachable compounds (E&Ls). E&Ls may be inherently toxic or may contaminate or interact with drug products, posing a potential danger to patients. Even as regulatory guidance related to the application, performance, and reporting of E&L studies increases and examples and data accumulate, E&L analysis is still an evolving area of investigation. DOWNLOAD