Evaluating Nitrosamines from Elastomers in Pharmaceutical Primary Packaging

Bettine Boltres

doi:10.5731/pdajpst.2021.012645

Review ArticleReview

Evaluating Nitrosamines from Elastomers in Pharmaceutical Primary Packaging

Bettine Boltres

PDA Journal of Pharmaceutical Science and Technology March 2022, 76 (2) 136-150; DOI: https://doi.org/10.5731/pdajpst.2021.012645

Bettine Boltres

Principal Scientific Affairs, Packaging & Delivery Systems, Scientific Affairs, West Pharmaceutical Services Deutschland GmbH & Co KG, Stolberger Str. 21 – 41, 52249 Eschweiler, Germany.

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: bettine.boltres@westpharma.com

Article
Figures & Data
References
Info & Metrics
PDF

Article Information

vol. 76 no. 2 136-150

DOI

https://doi.org/10.5731/pdajpst.2021.012645

PubMed

34282037

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online April 1, 2022.

Article Versions

previous version (July 19, 2021 - 10:39).
You are viewing the most recent version of this article.

Author Information

Bettine Boltres*

Principal Scientific Affairs, Packaging & Delivery Systems, Scientific Affairs, West Pharmaceutical Services Deutschland GmbH & Co KG, Stolberger Str. 21 – 41, 52249 Eschweiler, Germany.

↵* Corresponding Author: Principal Scientific Affairs, Packaging & Delivery Systems, Scientific Affairs, West Pharmaceutical Services Deutschland GmbH & Co KG, Stolberger Str. 21 – 41, 52249 Eschweiler, Germany; Telephone +49 (0) 152 22 77 74 70; E-mail: bettine.boltres{at}westpharma.com

View Full Text

Cited By...

10 Citations
Google Scholar

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

Regulatory Experiences with Root Causes and Risk Factors for Nitrosamine Impurities in Pharmaceuticals

Stephen Horne, Matthew D. Vera, Laxma R. Nagavelli, Vilayat A. Sayeed, Laurel Heckman, Deborah Johnson, Dan Berger, Yean Yean Yip, Carolina Lopes Krahn, Leticia Oyamada Sizukusa, Nayrton Flavio Moura Rocha, Robert N. Bream, Joachim Ludwig, David A. Keire, Gary Condran

Journal of Pharmaceutical Sciences 2023 112 5
Current Threat of Nitrosamines in Pharmaceuticals and Scientific Strategies for Risk Mitigation

Bodin Tuesuwan, Vorasit Vongsutilers

Journal of Pharmaceutical Sciences 2023 112 5
Simultaneous determination of 13 nitrosamine impurities in biological medicines using salting-out liquid-liquid extraction coupled with liquid chromatography tandem mass spectrometry

Feifei Luo, Yunya Liu, Yangguo Xie, Wei Hou, Lei Zhang, Zhongli Zhang

Journal of Pharmaceutical and Biomedical Analysis 2022 218
Nitrosamines crisis in pharmaceuticals − Insights on toxicological implications, root causes and risk assessment: A systematic review

Hemanth P.R. Vikram, Tegginamath Pramod Kumar, Gunjan Kumar, Narasimha M. Beeraka, Rajashree Deka, Sheik Mohammed Suhail, Sandeep Jat, Namitha Bannimath, Gayatiri Padmanabhan, Ravandur S. Chandan, Pramod Kumar, Bannimath Gurupadayya

Journal of Pharmaceutical Analysis 2024 14 5
A Novel Method for Monitoring N-Nitrosamines Impurities Using NH2-MIL-101(Fe) Mediated Dispersive Micro-Solid Phase Extraction Coupled with LC-MS/MS in Biopharmaceuticals

Yangguo Xie, Lei Zhang, Wei Hou, Ying Cheng, Feifei Luo, Zhuoyu Liu, Zhongli Zhang

Journal of Pharmaceutical Sciences 2023 112 11
Quantitative Analysis of NDMA in Drug Products: A Proposed High-Throughput Approach Using Headspace–SIFT-MS

Mark J. Perkins, Colin J. Hastie, Vaughan S. Langford

AppliedChem 2024 4 1
Nitrosamine Impurities in Herbal Formulations: A Review of Risks and Mitigation Strategies

Nunavath Raja Shekhar, Krishnaveni Nagappan, Madhu Tanya Singh, S. P. Dhanabal

Drug Research 2023 73 08
An Overview and Discussion of N-nitrosamine Considerations for Orally Inhaled Drug Products and Relevance to Other Dosage Forms

Hera Shams Khan, Fabienne Despres-Gnis, Cheryl L. M. Stults, James Mullis, Niran Nugara, Atish Sen, Lee Nagao

AAPS PharmSciTech 2023 24 1
Practical Application of Supercritical Fluid Chromatography for Pharmaceutical Research and Development

Paul Ferguson, Michael Hicks

2022 14
Reproductive and developmental toxicology of nitrosamines

Juan Liu, Wei Xu, Yi Liu, Qi Zhang

Toxicology Research 2025 14 2

PreviousNext

In This Issue

PDA Journal of Pharmaceutical Science and Technology

Vol. 76, Issue 2

March/April 2022

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 Evaluating Nitrosamines from Elastomers in Pharmaceutical Primary Packaging

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 * 13 + 1 =

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

Citation Tools

Evaluating Nitrosamines from Elastomers in Pharmaceutical Primary Packaging

Bettine Boltres

PDA Journal of Pharmaceutical Science and Technology Mar 2022, 76 (2) 136-150; DOI: 10.5731/pdajpst.2021.012645

Citation Manager Formats

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

Evaluating Nitrosamines from Elastomers in Pharmaceutical Primary Packaging

Bettine Boltres

PDA Journal of Pharmaceutical Science and Technology Mar 2022, 76 (2) 136-150; DOI: 10.5731/pdajpst.2021.012645

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...

No citing articles found.

Google Scholar

Keywords

Nitrosamines
Rubber
Elastomers
Pharmaceutical Primary Packaging

Main menu

User menu

Search

Evaluating Nitrosamines from Elastomers in Pharmaceutical Primary Packaging

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.