Strategies for Assessing Unknowns: Simulated Use Testing, Identification, or Pen and Paper Justification?
Extractable compounds with unknown identities are a common problem when conducting a chemical characterization study in support of medical device biocompatibility. With increasing instrument sensitivity, regulatory scrutiny, and the widespread adoption of the Analytical Evaluation Threshold (AET), unknown compounds are being seen in increasing number in many studies. Many manufacturers struggle to address and mitigate...