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Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2: The Errors of Inexact Identification and Inaccurate Quantitation
Dennis Jenke, Piet Christiaens, Jean-Marie Beusen, Phillipe Verlinde and Jan Baeten
PDA Journal of Pharmaceutical Science and Technology July 2019, pdajpst.2018.009779; DOI: https://doi.org/10.5731/pdajpst.2018.009779
Dennis Jenke
1 Triad Scientific Solutions;
Piet Christiaens
2 Nelson Labs
Jean-Marie Beusen
2 Nelson Labs
Phillipe Verlinde
2 Nelson Labs
Jan Baeten
2 Nelson Labs
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2: The Errors of Inexact Identification and Inaccurate Quantitation
Dennis Jenke, Piet Christiaens, Jean-Marie Beusen, Phillipe Verlinde, Jan Baeten
PDA Journal of Pharmaceutical Science and Technology Jul 2019, pdajpst.2018.009779; DOI: 10.5731/pdajpst.2018.009779
Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2: The Errors of Inexact Identification and Inaccurate Quantitation
Dennis Jenke, Piet Christiaens, Jean-Marie Beusen, Phillipe Verlinde, Jan Baeten
PDA Journal of Pharmaceutical Science and Technology Jul 2019, pdajpst.2018.009779; DOI: 10.5731/pdajpst.2018.009779
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- The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation
- Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables
- Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 3--Considering Errors of Implementation and the Use of a Database to Judge and Promote Good Science and Efficient Practices