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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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Abstract

Substances leached from materials used in pharmaceutical manufacturing systems, packages, and/or medical devices can be administered to a patient as part of a clinical therapy. These leachables can have an undesirable effect on the effectiveness of the therapy and/or patient safety. Thus, relevant samples such as material extracts or drug products are chromatographically screened for foreign organic impurities, where screening is the analytical process of discovering, identifying, and quantifying these unspecified foreign impurities. Although screening methods for organic extractables and leachables have achieved a high degree of technical and practical sophistication, they are not without issues with respect to their ability to accomplish the aforementioned three functions. In this first part of a series of three manuscripts, the process of screening is examined, limitations in screening are identified, and the concept of using an internally developed analytical database to identify, mitigate, or correct these errors is introduced. Furthermore, errors of omission are described, where an error of omission occurs when a screening method fails to produce a recognizable response to an analyte present in the test sample. The error may be that no response is produced (“falling through the cracks”) or that a produced response is not recognizable (“failing to see the tree for the forest”). In either case, proper use of a robust internal extractables/leachables database can decrease the frequency with which errors of omission occur. Examples of omission errors, their causes, and their possible resolution are discussed.

  • Extractables
  • Leachables
  • Chromatographic analysis
  • Screening analysis
  • Target analysis
  • Quantitation
  • Identification
  • Database
  • Errors of omission
  • © PDA, Inc. 2020
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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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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
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Cited By...

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

  • Extractables
  • Leachables
  • Chromatographic analysis
  • Screening analysis
  • Target analysis
  • Quantitation
  • Identification
  • Database
  • Errors of omission

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