Skip to main content

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
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
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: Lydia.Breckenridge@bms.com
Yusuf Oni
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Christina Evans
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Jason Franck
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Sharla Wood
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Meng Xu
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Erinc Sahin
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Brian Zacour
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

References

  1. 1.↵
    U.S. Food and Drug Administration, Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics. Chemistry, Manufacturing, and Control Documentation. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 1999.
  2. 2.↵
    U.S. Pharmacopeial Convention, General Chapter <232> Elemental Impurities—Limits. In USP 41—NF 36, USP: Rockville, MD, 2018; pp 6147–6151.
  3. 3.↵
    U.S. Pharmacopeial Convention, General Chapter <233> Elemental Impurities—Procedures. In USP 41—NF 36, USP: Rockville, MD, 2018; pp 6151–6455.
  4. 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.
  5. 5.↵
    International Conference for Harmonization. Q3D Elemental Impurities Guidance for Industry, ICH: Geneva, 2015.
  6. 6.↵
    1. Zdravkovic S. A.
    Comparison of a Lyophilized Drug Product to Other Solid and Liquid Media for the Extraction of Elastomeric Oligomers from a Butyl Rubber Stopper. PDA J. Pharm. Sci. Technol. 2017, 71 (6), 488–501.
    OpenUrlAbstract/FREE Full Text
  7. 7.↵
    1. Jenke D.
    A General Assessment of the Physiochemical Factors That Influence Leachables Accumulation in Pharmaceutical Drug Products and Related Solutions. PDA J. Pharm. Sci. Technol. 2011, 65 (2), 166–176.
    OpenUrlAbstract/FREE Full Text
  8. 8.↵
    1. Jenke D. R.
    Evaluation of Model Solvent Systems for Assessing the Accumulation of Container Extractables in Drug Formulations. Int J Pharm 2001, 224 (1–2), 51–60.
    OpenUrlPubMed
  9. 9.↵
    1. Zdravkovic S. A.
    Comparison of the Solubilization Properties of Polysorbate 80 and Isopropanol/Water Solvent Systems for Organic Compounds Extracted from Three Pharmaceutical Packaging Configurations. Eur. J. Pharm. Sci. 2016, 93, 475–483.
    OpenUrl
  10. 10.↵
    1. Jenke D.,
    2. Odufu A.,
    3. Poss M.
    The Effect of Solvent Polarity on the Accumulation of Leachables from Pharmaceutical Product Containers. Eur. J. Pharm. Sci. 2006, 27 (2–3), 133–142.
    OpenUrlPubMed
  11. 11.↵
    1. Shelby J. E.
    Introduction to Glass Science and Technology, 2nd ed.; Royal Society of Chemistry: Cambridge, U.K., 2005.
  12. 12.↵
    1. Clark D. E.,
    2. Zoitos B. K.
    1. White W. B.
    ; Theory of Corrosion of Glass and Ceramics. In Corrosion of Glass, Ceramics and Ceramic Superconductors: Principles, Testing, Characterization and Applications; Clark D. E., Zoitos B. K. Eds.; Noyes Publications: Park Ridge, NJ, 1992; pp 2–28.
  13. 13.↵
    1. Schaut R. A.,
    2. Porter Weeks W.
    Historical Review of Glasses Used for Parenteral Packaging. PDA J. Pharm. Sci. Technol. 2017, 71 (4), 279–296.
    OpenUrlAbstract/FREE Full Text
  14. 14.↵
    1. Nema S.,
    2. Ludwig J. D.
    1. Swift R.
    ; Glass Containers for Parenteral Products. In Pharmaceutical Dosage Forms—Parenteral Medications, 3rd ed; Nema S., Ludwig J. D., Eds.; Informa Healthcare: New York, 2012; Vol. 1, pp 287–304.
    OpenUrl
  15. 15.↵
    1. Kang J.,
    2. Lin X.,
    3. Penera J.
    Rapid Formulation Development for Monoclonal Antibodies. BioProcess Int. 2016, 14 (4), 40–47.
    OpenUrl
  16. 16.↵
    1. Van Hoecke K.,
    2. Catry C.,
    3. Vanhaecke F.
    Determination of Elemental Impurities in Leachate Solutions from Syringes Using Sector Field ICP-Mass Spectrometry. J Pharm. Biomed. Anal. 2013, 77, 139–144.
    OpenUrlPubMed
  17. 17.↵
    1. Solomon P.,
    2. Nelson J.
    Profiling Extractable and Leachable Inorganic Impurities in Ophthalmic Drug Containers by ICP-MS. Pharm. Dev. Technol. 2018, 23 (3), 247–254.
    OpenUrl
  18. 18.↵
    1. Dorival-Garcia N.,
    2. Carillo S.,
    3. Ta C.,
    4. Roberts D.,
    5. Comstock K.,
    6. Lofthouse S.,
    7. Ciceri E.,
    8. D'Silva K.,
    9. Kierans G.,
    10. Kaisermayer C.,
    11. Lindeberg A.,
    12. Bones J.
    Large-Scale Assessment of Extractables and Leachables in Single-Use Bags for Biomanufacturing. Anal. Chem. 2018, 90 (15), 9006–9015.
    OpenUrl
  19. 19.↵
    1. Chang J. Y.,
    2. Xiao N. J.,
    3. Zhu M.,
    4. Zhang J.,
    5. Hoff E.,
    6. Russell S.,
    7. Katta V.,
    8. Shire S. J.
    Leachables from Saline-Containing IV Bags Can Alter Therapeutic Protein Properties. Pharm. Res. 2010, 27 (11), 2402–2413.
    OpenUrlCrossRefPubMed
  20. 20.↵
    1. Menzel R.,
    2. Pahl I.,
    3. Loewe T.,
    4. Hauk A.
    Comparative Extractables Study of Autoclavable Polyethersulfone Filter Cartridges for Sterile Filtration. PDA J. Pharm. Sci. Technol. 2018, 72 (3), 298–316.
    OpenUrlAbstract/FREE Full Text
  21. 21.↵
    1. Schaut R. A.,
    2. Peanasky J. S.,
    3. DeMartino S. E.,
    4. Schiefelbein S. L.
    A New Glass Option for Parenteral Packaging. PDA J. Pharm. Sci. Technol. 2014, 68 (5), 527–534.
    OpenUrlAbstract/FREE Full Text
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 77 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 3
May/June 2023
  • Table of Contents
  • Index by Author
  • Complete Issue (PDF)
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Determination of ICH-Q3D Elemental Impurity Leachables in Glass Vials by Inductively Coupled Plasma Mass Spectrometry
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
5 + 9 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
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

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
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
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Experimental Method
    • Results and Discussion
    • Implications
    • Conclusion
    • Conflict of Interest Declaration
    • Acknowledgements
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • No citing articles found.
  • Google Scholar

More in this TOC Section

  • A Proof-of-Concept Study on a Universal Standard Kit to Evaluate the Risks of Inspectors for Their Foundational Ability of Visual Inspection of Injectable Drug Products
  • Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
  • Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
Show more Research

Similar Articles

Keywords

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

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire