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
Yusuf Oni
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
Christina Evans
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
Jason Franck
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
Sharla Wood
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
Meng Xu
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
Erinc Sahin
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
Brian Zacour
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903

References
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- 2.↵U.S. Pharmacopeial Convention, General Chapter <232> Elemental Impurities—Limits. In USP 41—NF 36, USP: Rockville, MD, 2018; pp 6147–6151.
- 3.↵U.S. Pharmacopeial Convention, General Chapter <233> Elemental Impurities—Procedures. In USP 41—NF 36, USP: Rockville, MD, 2018; pp 6151–6455.
- 4.↵U.S. Food and Drug Administration, Guidance for Industry: Q3D Elemental Impurities. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2020.
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 3
May/June 2023
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
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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