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

doi:10.5731/pdajpst.2018.009779

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;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: dennisjenke@triadscientificsolutions.com

Piet Christiaens

2 Nelson Labs

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Jean-Marie Beusen

2 Nelson Labs

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Phillipe Verlinde

2 Nelson Labs

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Jan Baeten

2 Nelson Labs

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Article
References
Info & Metrics
PDF

Article Information

pdajpst.2018.009779

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

Received December 8, 2018
Accepted June 17, 2019
Published online July 15, 2019.

Article Versions

You are currently viewing a previous version of this article (July 15, 2019 - 09:03).
View the most recent version of this article

Author Information

Dennis Jenke1,3 (dennisjenke{at}triadscientificsolutions.com),
Piet Christiaens2,
Jean-Marie Beusen2,
Phillipe Verlinde2 and
Jan Baeten2

¹ Triad Scientific Solutions;
² Nelson Labs

↵* Corresponding author; email: dennisjenke{at}triadscientificsolutions.com

Cited By...

7 Citations
Google Scholar

This article has been cited by the following articles in journals that are participating in Crossref Cited-by Linking.

Chemical Characterization and Non-targeted Analysis of Medical Device Extracts: A Review of Current Approaches, Gaps, and Emerging Practices

Eric M. Sussman, Berk Oktem, Irada S. Isayeva, Jinrong Liu, Samanthi Wickramasekara, Vaishnavi Chandrasekar, Keaton Nahan, Hainsworth Y. Shin, Jiwen Zheng

ACS Biomaterials Science & Engineering 2022 8 3
Development of a generic approach for monitoring leachable compounds in hospital pharmacy-prepared prefilled plastic packaging by ultrahigh-performance liquid chromatography coupled to high-resolution mass spectrometry with postcolumn infusion

William Bello, Julian Pezzatti, Markoulina Berger-Gryllaki, Serge Rudaz, Farshid Sadeghipour

Journal of Pharmaceutical and Biomedical Analysis 2023 236
Development of a generic sample preparation method using dispersive liquid–liquid microextraction for the monitoring of leachable compounds in hospital pharmacy-prepared prefilled drug products

William Bello, Julian Pezzatti, Serge Rudaz, Farshid Sadeghipour

Analytical Methods 2024 16 11
Identification and quantification of medical device extractables and leachables via non-target analysis (NTA); Analytical uncertainty

Dennis Jenke, Piet Christiaens, Ted Heise

Journal of Pharmaceutical and Biomedical Analysis 2024 241
A critical opinion-based review of hospital pharmacy compounding with respect to the risk of leachable substances due to the off-label use of plastic primary packaging

William Bello, Julian Pezzatti, Camille Stampfli, Laurent Carrez, Serge Rudaz, Farshid Sadeghipour

Therapeutic Advances in Drug Safety 2025 16
Extractables and Leachables

2022
Importance of a High Performing GC-MS Based Screening Method for Testing Stability Samples for Volatile and Semi-Volatile Leachable Impurities

Gyorgy Vas, Louis Fleck, Anna Michelson, Nicole Dunn, John Duett, Jacquelyn Cali

Reviews in Separation Sciences 2021 3 1

PreviousNext

In This Issue

PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 1

January/February 2025

Table of Contents
Index by Author
Complete Issue (PDF)

Download PDF

Article Alerts

User Name *

Password *

Email *

Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Your Email *

Your Name *

Send To *

Enter multiple addresses on separate lines or separate them with commas.

You are going to email the following Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2: The Errors of Inexact Identification and Inaccurate Quantitation

Message Subject (Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology

Message Body (Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.

Your Personal Message

CAPTCHA

This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Math question * 12 + 2 =

Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.

Citation Tools

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

Citation Manager Formats

BibTeX
Bookends
EasyBib
EndNote (tagged)
EndNote 8 (xml)
Medlars
Mendeley
Papers
RefWorks Tagged
Ref Manager
RIS
Zotero

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

Share This Article:

Tweet Widget
Facebook Like
Google Plus One

Jump to section

Article
References
Info & Metrics
PDF

No related articles found.

PubMed
Google Scholar

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

Google Scholar

Keywords

errors
Extractables
Identification
Leachables
Quantitation

Main menu

User menu

Search

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

Article Information

Article Versions

Author Information

Cited By...

In This Issue

Citation Manager Formats

Related Articles

Cited By...

More in this TOC Section

Similar Articles

Keywords

Readers

Author/Reviewer Information

Parenteral Drug Association, Inc.