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- Published online May 31, 2021.
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- previous version (November 16, 2020 - 09:31).
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© PDA, Inc. 2021
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- ↵* Corresponding Author: Triad Scientific Solutions, LLC, 181 Peregrine Ln., Hawthorn Woods, IL 60047; Telephone: (847) 393-3151; E-mail: dennisjenke{at}triadscientificsolutions.com
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- Article
- Abstract
- Introduction: Extractables, Leachables, and the Analytical Evaluation Threshold
- Problem Statement: The Analytical Evaluation Threshold Gap
- Filling the Analytical Evaluation Threshold Gap with the Uncertainty Factor
- Current Practice with Regard to Establishing the Magnitude of the Uncertainty Factor
- Issues with the Use of Large Uncertainty Factors to Adjust the Analytical Evaluation Threshold
- Managing the Uncertainty Adjustment
- Conclusion
- Conflict of Interest Declaration
- References
- Figures & Data
- References
- Info & Metrics
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