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Research ArticleTechnology/Application

Development of Conductivity Method as an Alternative to Titration for Hydrolytic Resistance Testing Used for Evaluation of Glass Vials Used in Pharmaceutical Industry

Kiyoshi Fujimori, Hans Lee, Joseph Phillips and Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology January 2017, 71 (1) 50-58; DOI: https://doi.org/10.5731/pdajpst.2016.007005
Kiyoshi Fujimori
Amgen Inc., Drug Product Development, Thousand Oaks, CA, USA
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Hans Lee
Amgen Inc., Drug Product Development, Thousand Oaks, CA, USA
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Joseph Phillips
Amgen Inc., Drug Product Development, Thousand Oaks, CA, USA
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Yasser Nashed-Samuel
Amgen Inc., Drug Product Development, Thousand Oaks, CA, USA
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  • For correspondence: snashed@amgen.com
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References

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    1. Guadagnino E.,
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    1. Jiang G.,
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    Novel Mechanism of Glass Delamination in Type 1A Borosilicate Vials Containing Frozen Protein Formulations. PDA J. Pharm. Sci. Technol. 2013, 67 (4), 323–335.
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    U.S. Food and Drug Administration. Safety Reports for Human Medical Products: Epoetin alfa (2010), Hyaluronidase Recombinant (2010), and Methotrexate (2013).
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    Chapter 3.2.1. Glass Containers for Pharmaceutical Use. In European Pharmacopoeia, 7th ed.; Council of Europe: Strasbourg, France, 2011.
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    General Chapter <660> Containers—Glass. In United States Pharmacopeia 35–National Formulary 30; U.S. Pharmacopeial Convention: Rockville, MD, 2012.
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    U.S. Food and Drug Administration (FDA). Guidance for Industry—Q2B Validation of Analytical Procedures: Methodology. FDA: Rockville, MD, 1996.
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PDA Journal of Pharmaceutical Science and Technology: 71 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 1
January/February 2017
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Development of Conductivity Method as an Alternative to Titration for Hydrolytic Resistance Testing Used for Evaluation of Glass Vials Used in Pharmaceutical Industry
Kiyoshi Fujimori, Hans Lee, Joseph Phillips, Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology Jan 2017, 71 (1) 50-58; DOI: 10.5731/pdajpst.2016.007005

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Development of Conductivity Method as an Alternative to Titration for Hydrolytic Resistance Testing Used for Evaluation of Glass Vials Used in Pharmaceutical Industry
Kiyoshi Fujimori, Hans Lee, Joseph Phillips, Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology Jan 2017, 71 (1) 50-58; DOI: 10.5731/pdajpst.2016.007005
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Keywords

  • Glass
  • Vials
  • Delamination
  • Alkalinity
  • conductivity

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