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OtherTechnology/Application

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;
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  • For correspondence: dennisjenke@triadscientificsolutions.com
Piet Christiaens
2 Nelson Labs
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Jean-Marie Beusen
2 Nelson Labs
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Phillipe Verlinde
2 Nelson Labs
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Jan Baeten
2 Nelson Labs
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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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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, Jan Baeten
PDA Journal of Pharmaceutical Science and Technology Jul 2019, pdajpst.2018.009779; DOI: 10.5731/pdajpst.2018.009779

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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, Jan Baeten
PDA Journal of Pharmaceutical Science and Technology Jul 2019, pdajpst.2018.009779; DOI: 10.5731/pdajpst.2018.009779
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Cited By...

  • Correlating GC/MS Relative Response Factors to Analytes Physicochemical and Chromatographic Properties to Facilitate the Quantitation of Organic Extractables and Leachables in Non-Targeted Analysis (NTA). Concepts and Empirical Considerations
  • Accurate or Protective: What Is the Goal of Non-Targeted Extractables and Leachables Quantitation and Identification?
  • 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
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Keywords

  • errors
  • Extractables
  • Identification
  • Leachables
  • Quantitation

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