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PDA Journal of Pharmaceutical Science and Technology

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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.
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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).
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© PDA, Inc. 2022

Author Information

  1. Bettine Boltres*
  1. Principal Scientific Affairs, Packaging & Delivery Systems, Scientific Affairs, West Pharmaceutical Services Deutschland GmbH & Co KG, Stolberger Str. 21 – 41, 52249 Eschweiler, Germany.
  1. ↵* 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
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PDA Journal of Pharmaceutical Science and Technology: 76 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 2
March/April 2022
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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

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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
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  • Article
    • Abstract
    • Introduction
    • Chemical Background
    • Nitrosamines in Industry
    • Nitrosamines in the Pharmaceutical Industry
    • Regulatory Framework
    • Toxicological Assessment
    • Nitrosamines in Rubber
    • Analyzing Rubber Components
    • Hazard Assessment
    • Conclusion
    • Conflict of Interest Declaration
    • Acknowledgements
    • References
  • Figures & Data
  • Info & Metrics
  • References
  • PDF

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Keywords

  • Nitrosamines
  • Rubber
  • Elastomers
  • Pharmaceutical Primary Packaging

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