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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleTechnology/Application

Development of an Inductively Coupled Plasma Mass Spectrometry Method for Quantification of Extracted Tungsten from Glass Prefilled Syringes Used as a Primary Packaging for Pharmaceutical and Therapeutic Protein Products

Kiyoshi Fujimori, Hans Lee, Joseph Phillips and Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 670-679; DOI: https://doi.org/10.5731/pdajpst.2013.00941
Kiyoshi Fujimori
Department of Drug Product Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA
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  • For correspondence: kiyoshif@amgen.com snashed@amgen.com
Hans Lee
Department of Drug Product Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA
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Joseph Phillips
Department of Drug Product Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA
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Yasser Nashed-Samuel
Department of Drug Product Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA
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  • For correspondence: kiyoshif@amgen.com snashed@amgen.com
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Article Information

vol. 67 no. 6 670-679
DOI 
https://doi.org/10.5731/pdajpst.2013.00941
PubMed 
24265307

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online November 21, 2013.

Copyright & Usage 
© PDA, Inc. 2013

Author Information

  1. Kiyoshi Fujimori*,
  2. Hans Lee,
  3. Joseph Phillips and
  4. Yasser Nashed-Samuel*
  1. Department of Drug Product Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA
  1. ↵*Corresponding Authors: Kiyoshi Fujimori: Amgen Inc., One Amgen Center Drive, 30E-0-B, Thousand Oaks, CA 91320, USA. Phone (805)313-4818, E-mail: kiyoshif{at}amgen.com; Yasser Nashed-Samuel: Amgen Inc., One Amgen Center Drive, 30E-1-C, Thousand Oaks, CA 91320, USA. Phone (805)447-5483, E-mail: snashed{at}amgen.com
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PDA Journal of Pharmaceutical Science and Technology: 67 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 6
November/December 2013
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Development of an Inductively Coupled Plasma Mass Spectrometry Method for Quantification of Extracted Tungsten from Glass Prefilled Syringes Used as a Primary Packaging for Pharmaceutical and Therapeutic Protein Products
Kiyoshi Fujimori, Hans Lee, Joseph Phillips, Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 670-679; DOI: 10.5731/pdajpst.2013.00941

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Development of an Inductively Coupled Plasma Mass Spectrometry Method for Quantification of Extracted Tungsten from Glass Prefilled Syringes Used as a Primary Packaging for Pharmaceutical and Therapeutic Protein Products
Kiyoshi Fujimori, Hans Lee, Joseph Phillips, Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 670-679; DOI: 10.5731/pdajpst.2013.00941
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    • I. Introduction
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Cited By...

  • Characterization of Protein Aggregating Tungstates: Electrospray Mass Spectrometry Analysis of Extracts from Prefilled Syringes and from Tungsten Pins Used in the Manufacture of Syringes
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More in this TOC Section

  • Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
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Keywords

  • Extractable
  • leachable
  • prefilled syringe
  • Tungsten
  • ICP/MS

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