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Research ArticleResearch

A Mechanistic Understanding of Polysorbate 80 Oxidation in Histidine and Citrate Buffer Systems—Part 2

Laura M. Doyle (Drbohlav), Anant Navanithan Sharma, Ganapathy Gopalrathnam, Lihua Huang and Scott Bradley
PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 320-330; DOI: https://doi.org/10.5731/pdajpst.2018.009639
Laura M. Doyle (Drbohlav)
1Department of Pharmaceutical Chemistry, University of Kansas, Simons Biosciences Research Laboratories, 2095 Constant Ave. Lawrence, KS 66047;
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Anant Navanithan Sharma
2Bioproduct Pharma Design, Lilly Research Laboratories, Eli Lilly and Company, 1400 West Raymond St., Indianapolis, IN 46221;
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  • For correspondence: sharma_anant_n@lilly.com
Ganapathy Gopalrathnam
2Bioproduct Pharma Design, Lilly Research Laboratories, Eli Lilly and Company, 1400 West Raymond St., Indianapolis, IN 46221;
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Lihua Huang
3Protein Characterization, Lilly Research Laboratories, Eli Lilly and Company, 1400 West Raymond St., Indianapolis, IN 46221;
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Scott Bradley
4Analytical Development, Lilly Research Laboratories, Eli Lilly and Company, 1400 West Raymond St., Indianapolis, IN 46221
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Article Information

vol. 73 no. 4 320-330
DOI 
https://doi.org/10.5731/pdajpst.2018.009639
PubMed 
30770486

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online August 6, 2019.

Article Versions

  • previous version (February 15, 2019 - 07:38).
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Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. Laura M. Doyle (Drbohlav)1,
  2. Anant Navanithan Sharma2,*,
  3. Ganapathy Gopalrathnam2,
  4. Lihua Huang3 and
  5. Scott Bradley4
  1. 1Department of Pharmaceutical Chemistry, University of Kansas, Simons Biosciences Research Laboratories, 2095 Constant Ave. Lawrence, KS 66047;
  2. 2Bioproduct Pharma Design, Lilly Research Laboratories, Eli Lilly and Company, 1400 West Raymond St., Indianapolis, IN 46221;
  3. 3Protein Characterization, Lilly Research Laboratories, Eli Lilly and Company, 1400 West Raymond St., Indianapolis, IN 46221;
  4. 4Analytical Development, Lilly Research Laboratories, Eli Lilly and Company, 1400 West Raymond St., Indianapolis, IN 46221
  1. ↵* Corresponding Author: Bioproduct Pharma Design, Lilly Research Laboratories, Eli Lilly and Company, 1400 West Raymond St., Indianapolis, IN 46221; Phone: 317-701-2376; E-mail: sharma_anant_n{at}lilly.com
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    International Journal of Pharmaceutics: X 2022 4
  • Comparative analysis and mechanistic insights into polysorbate 80 stability differences in biopharmaceutical buffer systems
    Zhuan Cheng, Pengzhen Wang, Luting Liu, Quanmin Chen, Jeremy Guo
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PDA Journal of Pharmaceutical Science and Technology: 73 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 4
July/August 2019
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A Mechanistic Understanding of Polysorbate 80 Oxidation in Histidine and Citrate Buffer Systems—Part 2
Laura M. Doyle (Drbohlav), Anant Navanithan Sharma, Ganapathy Gopalrathnam, Lihua Huang, Scott Bradley
PDA Journal of Pharmaceutical Science and Technology Jul 2019, 73 (4) 320-330; DOI: 10.5731/pdajpst.2018.009639

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A Mechanistic Understanding of Polysorbate 80 Oxidation in Histidine and Citrate Buffer Systems—Part 2
Laura M. Doyle (Drbohlav), Anant Navanithan Sharma, Ganapathy Gopalrathnam, Lihua Huang, Scott Bradley
PDA Journal of Pharmaceutical Science and Technology Jul 2019, 73 (4) 320-330; DOI: 10.5731/pdajpst.2018.009639
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Keywords

  • Polysorbate 80 (PS 80)
  • oxidation
  • histidine
  • Citrate
  • Phosphate
  • Fe2+
  • EDTA
  • stainless steel
  • Temperature
  • Light

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