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Research ArticleRESEARCH

Identification of an Extraneous Black Particle in a Glass Syringe: Extractables/Leachables Case Study

Yasser Nashed-Samuel, Gianni Torraca, Dengfeng Liu, Kiyoshi Fujimori, Zhongqi Zhang, Zai-Qing Wen and Hans Lee
PDA Journal of Pharmaceutical Science and Technology May 2010, 64 (3) 242-248;
Yasser Nashed-Samuel
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  • For correspondence: snashed@amgen.com
Gianni Torraca
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Dengfeng Liu
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Kiyoshi Fujimori
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Zhongqi Zhang
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Zai-Qing Wen
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Hans Lee
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References

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    Tungsten Leaching from Prefilled Syringes and Impact on Protein Aggregation. Poster presented at the PDA Extractables/Leachables Forum: Confronting Extractables and Leachables Issues in an Evolving Industry; Bethesda, Maryland, November 6–8, 2007.
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    ; Plastic Additives Handbook, 5th Ed.; Hanser Gardner Publications, Inc.: Cincinnati, OH, 2001; pp 171–175 and 546–548.
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    Identification of caprolactam oligomers and related compounds in aqueous extracts of Nylon-6. J. Appl. Polym Sci. 2005, 95 (5), 1262–1274.
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PDA Journal of Pharmaceutical Science and Technology: 64 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 64, Issue 3
May/June 2010
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Identification of an Extraneous Black Particle in a Glass Syringe: Extractables/Leachables Case Study
Yasser Nashed-Samuel, Gianni Torraca, Dengfeng Liu, Kiyoshi Fujimori, Zhongqi Zhang, Zai-Qing Wen, Hans Lee
PDA Journal of Pharmaceutical Science and Technology May 2010, 64 (3) 242-248;

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Identification of an Extraneous Black Particle in a Glass Syringe: Extractables/Leachables Case Study
Yasser Nashed-Samuel, Gianni Torraca, Dengfeng Liu, Kiyoshi Fujimori, Zhongqi Zhang, Zai-Qing Wen, Hans Lee
PDA Journal of Pharmaceutical Science and Technology May 2010, 64 (3) 242-248;
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Cited By...

  • Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
  • Characterization of Protein Aggregating Tungstates: Electrospray Mass Spectrometry Analysis of Extracts from Prefilled Syringes and from Tungsten Pins Used in the Manufacture of Syringes
  • The Use of TOC Reconciliation as a Means of Establishing the Degree to Which Chromatographic Screening of Plastic Material Extracts for Organic Extractables Is Complete
  • 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
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