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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleTechnology/Application

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?

Dennis Jenke, Piet Christiaens, Philippe Verlinde, Jan Baeten and Jean-Marie Beusen
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 236-247; DOI: https://doi.org/10.5731/pdajpst.2021.012673
Dennis Jenke
1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium; and
2Triad Scientific Solutions, LLC 181 Peregrine Lane, Hawthorn Woods, IL 60047
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  • For correspondence: dennisjenke@triadscientificsolutions.com
Piet Christiaens
1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium; and
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Philippe Verlinde
1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium; and
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Jan Baeten
1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium; and
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Jean-Marie Beusen
1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium; and
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References

  1. 1.↵
    1. Jenke D.,
    2. Odufu A.
    Utilization of Internal Standard Response Factors to Estimate the Concentration of Organic Compounds Leached from Pharmaceutical Packaging Systems and Application of Such Estimated Concentrations to Safety Assessment. J. Chromatogr. Sci. 2012, 50 (3), 206–212.
    OpenUrlCrossRefPubMed
  2. 2.↵
    1. Zdravkovic S. A.,
    2. Duong C. T.,
    3. Hellenbrand A. A.,
    4. Duff S. R.,
    5. Dreger A. L.
    Establishment of a Reference Standard Database for Use in the Qualitative and Semi-Quantitative Analysis of Pharmaceutical Contact Materials within an Extractables Survey by GC-MS. J. Pharm. Biomed. Anal. 2018, 151 49–60.
    OpenUrl
  3. 3.↵
    1. Christiaens P.,
    2. Beusen J.-M.,
    3. Verlinde P.,
    4. Baeten J.,
    5. Jenke D.
    Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part I: Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Error of Omission. PDA J. Pharm. Sci. Technol. 2020, 74 (1), 90–107.
    OpenUrlAbstract/FREE Full Text
  4. 4.↵
    1. Jenke D.
    Standardization of Chromatographic Screening Methods for Organic Extractables and Leachables by Managing Outcomes. PDA J. Pharm. Sci. Technol., in press.
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PDA Journal of Pharmaceutical Science and Technology: 76 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 3
May/June 2022
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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?
Dennis Jenke, Piet Christiaens, Philippe Verlinde, Jan Baeten, Jean-Marie Beusen
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 236-247; DOI: 10.5731/pdajpst.2021.012673

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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?
Dennis Jenke, Piet Christiaens, Philippe Verlinde, Jan Baeten, Jean-Marie Beusen
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 236-247; DOI: 10.5731/pdajpst.2021.012673
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Cited By...

  • Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
  • 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?
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Keywords

  • Extractables
  • Leachables
  • Screening
  • Quantitation
  • Accuracy

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