Research ArticleResearch
Development and Validation of a Customized Amplex UltraRed Assay for Sensitive Hydrogen Peroxide Detection in Pharmaceutical Water
Alexandra H. Heussner, Marlene Hermann and Melanie Zerulla-Wernitz
PDA Journal of Pharmaceutical Science and Technology September 2024, 78 (5) 548-559; DOI: https://doi.org/10.5731/pdajpst.2022.012758
Alexandra H. Heussner
1Analytical Science Laboratory, Development Service, Vetter Pharma-Fertigung GmbH & Co. KG, Schuetzenstrasse 87, 88212 Ravensburg, Germany
Marlene Hermann
1Analytical Science Laboratory, Development Service, Vetter Pharma-Fertigung GmbH & Co. KG, Schuetzenstrasse 87, 88212 Ravensburg, Germany
Melanie Zerulla-Wernitz
1Analytical Science Laboratory, Development Service, Vetter Pharma-Fertigung GmbH & Co. KG, Schuetzenstrasse 87, 88212 Ravensburg, Germany
References
- 1.↵
- Eisner D. R.,
- Hubbard A.,
- Eppler K.,
- Tegoulia V.,
- Maa Y.-F.
- 2.↵
- Eisner D. R.,
- Hui A.,
- Eppler K.,
- Tegoulia V.,
- Maa Y.-F.
- 3.↵
- Hubbard A.,
- Roedl T.,
- Hui A.,
- Knueppel S.,
- Eppler K.,
- Lehnert S.,
- Maa Y.-F.
- 4.↵
- Hui A.,
- Lam X. M.,
- Kuehl C.,
- Grauschopf U.,
- Wang Y. J.
- 5.↵
- Zhou M.,
- Diwu Z.,
- Panchuk-Voloshina N.,
- Haugland R. P.
- 6.↵
- 7.↵
- Towne V.,
- Will M.,
- Oswald B.,
- Zhao Q.
- 8.↵
- 9.↵
- Gomes A.,
- Fernandes E.,
- Lima J. L. F. C.
- 10.↵
- Schumb W. C.
- 11.↵
- Schumb W. C.
- 12.↵
- Abel E.
- 13.↵International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Quality Guideline Q2(R1): Validation of Analytical Procedures: Text and Methodology. ICH: Geneva, 2005.
- 14.↵
- Ermer J.,
- Nethercote P. W.
- 15.↵U.S. Food and Drug Administration. Guidance for Industry: Bioanalytical Method Validation. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2018.
- 16.↵International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Quality Guideline Q2(R2): Validation of Analytical Procedures. ICH: Geneva, 2023.
- 17.↵International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Quality Guideline Q14: Analytical Procedure Development. ICH: Geneva, 2023.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 5
September/October 2024
Development and Validation of a Customized Amplex UltraRed Assay for Sensitive Hydrogen Peroxide Detection in Pharmaceutical Water
Alexandra H. Heussner, Marlene Hermann, Melanie Zerulla-Wernitz
PDA Journal of Pharmaceutical Science and Technology Sep 2024, 78 (5) 548-559; DOI: 10.5731/pdajpst.2022.012758
Development and Validation of a Customized Amplex UltraRed Assay for Sensitive Hydrogen Peroxide Detection in Pharmaceutical Water
Alexandra H. Heussner, Marlene Hermann, Melanie Zerulla-Wernitz
PDA Journal of Pharmaceutical Science and Technology Sep 2024, 78 (5) 548-559; DOI: 10.5731/pdajpst.2022.012758
Jump to section
Related Articles
- No related articles found.
Cited By...
- No citing articles found.