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Research ArticleResearch

Determination of ICH-Q3D Elemental Impurity Leachables in Glass Vials by Inductively Coupled Plasma Mass Spectrometry

Lydia Breckenridge, Yusuf Oni, Christina Evans, Jason Franck, Sharla Wood, Meng Xu, Erinc Sahin and Brian Zacour
PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 197-210; DOI: https://doi.org/10.5731/pdajpst.2021.012655
Lydia Breckenridge
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
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  • For correspondence: Lydia.Breckenridge@bms.com
Yusuf Oni
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
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Christina Evans
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
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Jason Franck
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
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Sharla Wood
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
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Meng Xu
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
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Erinc Sahin
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
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Brian Zacour
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
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Article Information

vol. 77 no. 3 197-210
DOI 
https://doi.org/10.5731/pdajpst.2021.012655
PubMed 
36241213

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online June 8, 2023.

Article Versions

  • previous version (October 14, 2022 - 02:53).
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© PDA, Inc. 2023

Author Information

  1. Lydia Breckenridge*,
  2. Yusuf Oni,
  3. Christina Evans,
  4. Jason Franck,
  5. Sharla Wood,
  6. Meng Xu,
  7. Erinc Sahin and
  8. Brian Zacour
  1. Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
  1. ↵*Corresponding Author: 1 Squibb Drive, New Brunswick, NJ 08903; Telephone: (732) 227-7540; E-mail: Lydia.Breckenridge@bms.com
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  • ICH-Q3D based elemental impurities study in an oral drug product: Risk assessment according to the component approach (option 2b) confirmed by the finished product analysis (option 3)
    Ayoub Hamidallah, Mohamed Yafout, Ibrahim Sbai El Otmani
    Annales Pharmaceutiques Françaises 2025
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PDA Journal of Pharmaceutical Science and Technology: 77 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 3
May/June 2023
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Determination of ICH-Q3D Elemental Impurity Leachables in Glass Vials by Inductively Coupled Plasma Mass Spectrometry
Lydia Breckenridge, Yusuf Oni, Christina Evans, Jason Franck, Sharla Wood, Meng Xu, Erinc Sahin, Brian Zacour
PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 197-210; DOI: 10.5731/pdajpst.2021.012655
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Keywords

  • Elemental impurities
  • ICH-Q3D
  • Leachables
  • ICP-MS
  • Glass vials
  • Metals

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Determination of ICH-Q3D Elemental Impurity Leachables in Glass Vials by Inductively Coupled Plasma Mass Spectrometry
Lydia Breckenridge, Yusuf Oni, Christina Evans, Jason Franck, Sharla Wood, Meng Xu, Erinc Sahin, Brian Zacour
PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 197-210; DOI: 10.5731/pdajpst.2021.012655

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