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Research ArticleTechnology/Application

Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2—Errors of Inexact Identification and Inaccurate Quantitation

Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 108-133; DOI: https://doi.org/10.5731/pdajpst.2018.009779
Piet Christiaens
1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium
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Jean-Marie Beusen
1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium
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Philippe Verlinde
1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium
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Jan Baeten
1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium
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Dennis Jenke
1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium
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  • For correspondence: dennisjenke@triadscientificsolutions.com
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Article Information

vol. 74 no. 1 108-133
DOI 
https://doi.org/10.5731/pdajpst.2018.009779
PubMed 
31308065

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online February 3, 2020.

Article Versions

  • previous version (July 15, 2019 - 09:03).
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Copyright & Usage 
© PDA, Inc. 2020

Author Information

  1. Piet Christiaens1,
  2. Jean-Marie Beusen1,
  3. Philippe Verlinde1,
  4. Jan Baeten1 and
  5. Dennis Jenke1,*
  1. 1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium
  1. ↵* Corresponding Author: Triad Scientific Solutions, LLC, 181 Peregrine Lane, Hawthorn Woods, IL 60047; Telephone: (1)-847-393-3151; e-mail: dennisjenke@triadscientificsolutions.com
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PDA Journal of Pharmaceutical Science and Technology: 74 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 1
January/February 2020
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Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2—Errors of Inexact Identification and Inaccurate Quantitation
Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten, Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 108-133; 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

  • Extractables
  • Leachables
  • Chromatographic analysis
  • Screening analysis
  • Identification
  • Database
  • Quantitation
  • Internal standard
  • Response factor

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Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2—Errors of Inexact Identification and Inaccurate Quantitation
Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten, Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 108-133; DOI: 10.5731/pdajpst.2018.009779

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