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Research ArticleTechnology/Application

Classification of Glass Particles in Parenteral Product Vials by Visual, Microscopic, and Spectroscopic Methods

“Gary” Guiyang Li, Shawn Cao, Nancy Jiao and Zai-Qing Wen
PDA Journal of Pharmaceutical Science and Technology July 2014, 68 (4) 362-372; DOI: https://doi.org/10.5731/pdajpst.2014.00986
“Gary” Guiyang Li
Department of Drug Product Development, Amgen Inc., Thousand Oaks, CA
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  • For correspondence: guiyangl@amgen.com
Shawn Cao
Department of Drug Product Development, Amgen Inc., Thousand Oaks, CA
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Nancy Jiao
Department of Drug Product Development, Amgen Inc., Thousand Oaks, CA
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Zai-Qing Wen
Department of Drug Product Development, Amgen Inc., Thousand Oaks, CA
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Article Information

vol. 68 no. 4 362-372
DOI 
https://doi.org/10.5731/pdajpst.2014.00986
PubMed 
25035258

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online July 17, 2014.

Copyright & Usage 
© PDA, Inc. 2014

Author Information

  1. “Gary” Guiyang Li*,
  2. Shawn Cao,
  3. Nancy Jiao and
  4. Zai-Qing Wen
  1. Department of Drug Product Development, Amgen Inc., Thousand Oaks, CA
  1. ↵* Corresponding Author: Guiyang Li, Senior Scientist, Ph.D., Drug Product Development, Amgen Inc., 1 Amgen Center Dr., B30 E2B, Thousand Oaks, CA 91320. Telephone 805-447-2875, email: guiyangl{at}amgen.com
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PDA Journal of Pharmaceutical Science and Technology: 68 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 4
July/August 2014
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Classification of Glass Particles in Parenteral Product Vials by Visual, Microscopic, and Spectroscopic Methods
“Gary” Guiyang Li, Shawn Cao, Nancy Jiao, Zai-Qing Wen
PDA Journal of Pharmaceutical Science and Technology Jul 2014, 68 (4) 362-372; DOI: 10.5731/pdajpst.2014.00986

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Classification of Glass Particles in Parenteral Product Vials by Visual, Microscopic, and Spectroscopic Methods
“Gary” Guiyang Li, Shawn Cao, Nancy Jiao, Zai-Qing Wen
PDA Journal of Pharmaceutical Science and Technology Jul 2014, 68 (4) 362-372; DOI: 10.5731/pdajpst.2014.00986
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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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