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Research ArticleTechnology/Application

Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 1—Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Errors of Omission

Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 90-107; DOI: https://doi.org/10.5731/pdajpst.2018.009761
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 90-107
DOI 
https://doi.org/10.5731/pdajpst.2018.009761
PubMed 
31209164

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

Article Versions

  • previous version (June 17, 2019 - 04:45).
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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, USA. 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 1—Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Errors of Omission
Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten, Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 90-107; DOI: 10.5731/pdajpst.2018.009761
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  • Article
    • Abstract
    • Introduction
    • Analytics of Organic Extractables and Leachables
    • Limitations of the Chromatographic Screening Process
    • Addressing the Limitations via an Internal Extractables and Leachables Database
    • An Example of an Internal Extractables and Leachables Database
    • Errors of Omission, a Fatal Error
    • Concluding Thoughts
    • Conflict of Interest Declaration
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Cited By...

  • Is Retention Time and/or Structure Matching a Solution to the Challenge of Providing Quantitative Data When Screening for Extractables and Leachables by GC/MS?
  • Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2--Errors of Inexact Identification and Inaccurate Quantitation
  • 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
  • Target analysis
  • Quantitation
  • Identification
  • Database
  • Errors of omission

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Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 1—Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Errors of Omission
Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten, Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 90-107; DOI: 10.5731/pdajpst.2018.009761

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