Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables

Dennis Jenke

doi:10.5731/pdajpst.2019.010520

Article CommentaryCommentary

Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables

Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 348-358; DOI: https://doi.org/10.5731/pdajpst.2019.010520

Dennis Jenke

Triad Scientific Solutions, LLC

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

Article
Figures & Data
References
Info & Metrics
PDF

Article Information

vol. 74 no. 3 348-358

DOI

https://doi.org/10.5731/pdajpst.2019.010520

PubMed

32295860

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online May 26, 2020.

Article Versions

previous version (April 15, 2020 - 10:05).
You are viewing the most recent version of this article.

Author Information

Dennis Jenke

Triad Scientific Solutions, LLC

Corresponding Author: Triad Scientific Solutions, LLC, 181 Peregrine Lane, Hawthorn Woods, IL 60047. Telephone (847) 393-3151; E-mail: dennisjenke{at}triadscientificsolutions.com

View Full Text

Cited By...

5 Citations
Google Scholar

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

Analytical challenges and recent advances in the identification and quantitation of extractables and leachables in pharmaceutical and medical products

Gagandeep Singh, Dujuan Lu, Chongming Liu, Danny Hower

TrAC Trends in Analytical Chemistry 2021 141
Determination of Response Factors for Analytes Detected during Migration Studies, Strategy and Internal Standard Selection for Risk Minimization

Nikolaos Kritikos, Anna Bletsou, Christina Konstantinou, Antonios-Dionysios Neofotistos, Constantinos Kousoulos, Yannis Dotsikas

Molecules 2023 28 15
Equivalence study of extractables from single-use biopharmaceutical manufacturing equipment after X-ray or gamma irradiation

Roberto Menzel, Ina Pahl, Samuel Dorey, Tanja Maier, Armin Hauk

International Journal of Pharmaceutics 2023 634
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. 74, Issue 3

May/June 2020

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 Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables

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 * 4 + 11 =

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

Citation Tools

Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables

Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 348-358; DOI: 10.5731/pdajpst.2019.010520

Citation Manager Formats

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

Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 348-358; DOI: 10.5731/pdajpst.2019.010520

Share This Article:

Tweet Widget
Facebook Like
Google Plus One

Jump to section

Article
Figures & Data
References
Info & Metrics
PDF

No related articles found.

PubMed
Google Scholar

Cited By...

A Practical Derivation of the Uncertainty Factor Applied to Adjust the Extractables/Leachables Analytical Evaluation Threshold (AET) for Response Factor Variation

Google Scholar

Keywords

Extractables
Leachables
Analytical evaluation threshold
Quantitation
uncertainty factor
Safety risk assessment

Main menu

User menu

Search

Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables

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.