A Compilation of Safety Impact Information for Extractables Associated with Materials Used in Pharmaceutical Packaging, Delivery, Administration, and Manufacturing Systems

Dennis Jenke; Tage Carlson

doi:10.5731/pdajpst.2014.00995

Research ArticleResearch

A Compilation of Safety Impact Information for Extractables Associated with Materials Used in Pharmaceutical Packaging, Delivery, Administration, and Manufacturing Systems

Dennis Jenke and Tage Carlson

PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 407-455; DOI: https://doi.org/10.5731/pdajpst.2014.00995

Dennis Jenke

Baxter Healthcare Corporation, Round Lake, IL

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

Tage Carlson

Baxter Healthcare Corporation, Round Lake, IL

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. 68 no. 5 407-455

DOI

https://doi.org/10.5731/pdajpst.2014.00995

PubMed

25336416

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online October 21, 2014.

Author Information

Dennis Jenke* and
Tage Carlson

Baxter Healthcare Corporation, Round Lake, IL

↵*Corresponding Author: 25212 West Illinois Route 120, Baxter Healthcare Corporation, Round Lake, IL 60073. Telephone: (224) 270-5821; e-mail: dennis_jenke{at}baxter.com

View Full Text

Cited By...

24 Citations
Google Scholar

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

Leachables from plastic materials in contact with drugs. State of the art and review of current analytical approaches

Luis Cuadros-Rodríguez, Marta Lazúen-Muros, Cristina Ruiz-Samblás, Natalia Navas-Iglesias

International Journal of Pharmaceutics 2020 583
Large-Scale Assessment of Extractables and Leachables in Single-Use Bags for Biomanufacturing

Noemí Dorival-García, Sara Carillo, Christine Ta, Dominic Roberts, Kate Comstock, Simon Lofthouse, Elena Ciceri, Kyle D’Silva, Gerald Kierans, Christian Kaisermayer, Anna Lindeberg, Jonathan Bones

Analytical Chemistry 2018 90 15
Identification, analysis and safety assessment of leachables and extractables

Dennis Jenke

TrAC Trends in Analytical Chemistry 2018 101
Development and validation of an ultra-performance liquid chromatography method for the determination of bis(2,4-di- tert -butylphenyl)phosphate and related extractable compounds from single-use plastic films

Christine Ta, Jonathan Bones

Journal of Chromatography A 2017 1492
Non-Targeted Chemical Characterization of JUUL Virginia Tobacco Flavored Aerosols Using Liquid and Gas Chromatography

Mark R. Crosswhite, Patrick C. Bailey, Lena N. Jeong, Anastasia Lioubomirov, Clarissa Yang, Adam Ozvald, J. Brian Jameson, I. Gene Gillman

Separations 2021 8 9
Safety Risk Categorization of Organic Extractables Associated with Polymers used in Packaging, Delivery and Manufacturing Systems for Parenteral Drug Products

Dennis Jenke

Pharmaceutical Research 2015 32 3
Using extractables data from single-use components for extrapolation to process equipment-related leachables: The toolbox and justifications

Armin Hauk, Ina Pahl, Samuel Dorey, Roberto Menzel

European Journal of Pharmaceutical Sciences 2021 163
Non-Targeted Chemical Characterization of JUUL-Menthol-Flavored Aerosols Using Liquid and Gas Chromatography

Mark R. Crosswhite, Lena N. Jeong, Patrick C. Bailey, J. Brian Jameson, Anastasia Lioubomirov, David Cook, Clarissa Yang, Adam Ozvald, Matthew Lyndon, I. Gene Gillman

Separations 2022 9 11
Application of dispersive liquid–liquid microextraction based on solidification of floating organic drop for the determination of extractables from pharmaceutical packaging materials

Xuechun Sun, Xuebin Xing, Zhenxia Du

Talanta 2020 209
4-Hydroxynonenal – A Toxic Leachable from Clinically Used Administration Materials

Ariane Schröter, Hanns-Christian Mahler, Nadia Ben Sayed, Atanas V. Koulov, Jörg Huwyler, Michael Jahn

Journal of Pharmaceutical Sciences 2021 110 9
Prefilled dual chamber devices (DCDs) – Promising high-quality and convenient drug delivery system

Rahul G. Ingle, Wei-Jie Fang

International Journal of Pharmaceutics 2021 597
Identification of extractables by liquid chromatography-high resolution mass spectrometry: A case study to understand the extraction profile of different disposable syringes

Moolchand Kurmi, Shishir Prasad, Narayana Swamy Panduranga, Karthik Jayaraman, Hemant Bhutani

Journal of Pharmaceutical and Biomedical Analysis 2020 191
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
Does an interaction exist between ketamine hydrochloride and Becton Dickinson syringes?

M Closset, J D Hecq, E Gonzalez, B Bihin, J Jamart, L Galanti

European Journal of Hospital Pharmacy 2017 24 4
Identification of an Oxidizing Leachable from a Clinical Syringe Rubber Stopper

Ariane Schröter, Sonja Peter, Hanns-Christian Mahler, Andreas Zerr, Ombeline Danton, Pascal Chalus, Atanas V. Koulov, Jörg Huwyler, Michael Jahn

Journal of Pharmaceutical Sciences 2021 110 10
How sensitive does chemical characterization of medical devices need to be? Calibration of analytical evaluation thresholds with the carcinogenic potency database

Todd A. Kennedy, Mark J. Spinti

Regulatory Toxicology and Pharmacology 2021 122
Research on the relationship between cephalosporin structure, solution clarity, and rubber closure compatibility using volatile components profile of butyl rubber closures

Xiao-Meng Chong, Xin Dong, Shang-Chen Yao, Chang-Qin Hu

Drug Development and Industrial Pharmacy 2019 45 1
Study of leachable compounds in hospital pharmacy-compounded prefilled syringes, infusion bags and vials

William Bello, Julian Pezzatti, Serge Rudaz, Farshid Sadeghipour

Journal of Pharmaceutical Sciences 2024 113 11
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
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
Identification of nonvolatile organic compounds (NVOCs) in biopharmaceuticals through non-target analysis and quantification using complexation-precipitation extraction

Feifei Luo, Mengmeng Hao, Lei Zhang, Yangguo Xie, Wei Hou, Hongya Wang, Zhongli Zhang

Journal of Chromatography A 2024 1713
Setting impurity limits for endogenous substances: Recommendations for a harmonized procedure and an example using fatty acids

Robert A. Jolly, Suren Bandara, Joel Bercu, Courtney M. Callis, David G. Dolan, Jessica Graham, Diem HaMai, Ester Lovsin Barle, Andrew Maier, Melisa Masuda-Herrera, Chandrika Moudgal, Jillian A. Parker, John Reichard, Reena Sandhu, Ernest S. Fung

Regulatory Toxicology and Pharmacology 2022 134
Study of extractables and leachables of non‐polyvinyl chloride soft infusion bags from different batches by analytical assessment threshold screening

Zheng Lu, Xuechun Sun, Augustine Atta Debraha, Zhenxia Du

Packaging Technology and Science 2024 37 2

PreviousNext

In This Issue

PDA Journal of Pharmaceutical Science and Technology

Vol. 68, Issue 5

September/October 2014

Table of Contents
Index by Author

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 A Compilation of Safety Impact Information for Extractables Associated with Materials Used in Pharmaceutical Packaging, Delivery, Administration, and Manufacturing Systems

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 + 4 =

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

Citation Tools

A Compilation of Safety Impact Information for Extractables Associated with Materials Used in Pharmaceutical Packaging, Delivery, Administration, and Manufacturing Systems

Dennis Jenke, Tage Carlson

PDA Journal of Pharmaceutical Science and Technology Sep 2014, 68 (5) 407-455; DOI: 10.5731/pdajpst.2014.00995

Citation Manager Formats

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

A Compilation of Safety Impact Information for Extractables Associated with Materials Used in Pharmaceutical Packaging, Delivery, Administration, and Manufacturing Systems

Dennis Jenke, Tage Carlson

PDA Journal of Pharmaceutical Science and Technology Sep 2014, 68 (5) 407-455; DOI: 10.5731/pdajpst.2014.00995

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...

Using Extractables Data of Sterile Filter Components for Scaling Calculations
Assessment of Extractable Elements from Elastomers
Comparative Extractables Study of Autoclavable Polyethersulfone Filter Cartridges for Sterile Filtration
Does an interaction exist between ketamine hydrochloride and Becton Dickinson syringes?
Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products

Google Scholar

Keywords

Extractables
Leachables
Safety assessment
Thresholds
Risk index (RI)
Toxicological risk assessment

Main menu

User menu

Search

A Compilation of Safety Impact Information for Extractables Associated with Materials Used in Pharmaceutical Packaging, Delivery, Administration, and Manufacturing Systems

Article Information

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.