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Research ArticleTechnology/Application

Assessment of Extractable Elements from Elastomers

Diane Paskiet, Crystal Kraft, Erica Tullo, Jeff Hunter and Diego Zurbriggen
PDA Journal of Pharmaceutical Science and Technology January 2019, 73 (1) 83-91; DOI: https://doi.org/10.5731/pdajpst.2017.008193
Diane Paskiet
West Pharmaceutical Services, Inc. Exton, PA, USA.
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Crystal Kraft
West Pharmaceutical Services, Inc. Exton, PA, USA.
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Erica Tullo
West Pharmaceutical Services, Inc. Exton, PA, USA.
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Jeff Hunter
West Pharmaceutical Services, Inc. Exton, PA, USA.
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Diego Zurbriggen
West Pharmaceutical Services, Inc. Exton, PA, USA.
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  • For correspondence: diego.zurbriggen@westpharma.com
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PDA Journal of Pharmaceutical Science and Technology: 73 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 1
January/February 2019
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Assessment of Extractable Elements from Elastomers
Diane Paskiet, Crystal Kraft, Erica Tullo, Jeff Hunter, Diego Zurbriggen
PDA Journal of Pharmaceutical Science and Technology Jan 2019, 73 (1) 83-91; DOI: 10.5731/pdajpst.2017.008193
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  • Article
    • Abstract
    • Introduction
    • Guidance on Elemental Impurities Assessments
    • Study Design for Extractable Elements in Elastomers
    • Materials and Methods
    • Results and Discussion
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Keywords

  • Elastomer
  • Elemental impurities
  • Extractables and leachables
  • ICH Q3D
  • Parenteral packaging materials
  • USP <231>/<232>/<233>

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Assessment of Extractable Elements from Elastomers
Diane Paskiet, Crystal Kraft, Erica Tullo, Jeff Hunter, Diego Zurbriggen
PDA Journal of Pharmaceutical Science and Technology Jan 2019, 73 (1) 83-91; DOI: 10.5731/pdajpst.2017.008193

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