Article CommentaryCommentary
Standardization of Chromatographic Screening Methods for Organic Extractables and Leachables by Managing Outcomes
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology July 2023, 77 (4) 329-338; DOI: https://doi.org/10.5731/pdajpst.2021.012671
Dennis Jenke
Trial Scientific Solutions, LLC, 181 Peregrine Lane, Hawthorn Wood, IL 60047
References
- 1.↵
- Zdravkovic S. A.
- 2.↵
- Jenke D.
- 3.↵
- Posgia M.,
- Przygoda R.,
- Zhou Y.,
- Malek D.
- 4.↵
- Sawyer A. Y.
- 5.↵
- Heise T.,
- Sawyer A. Y.,
- Hirai T.,
- Schaible S.,
- Sy H.,
- Wickramasekara S.
- 6.↵
- Hammond M.,
- Nunn H.,
- Rogers G.,
- Lee H.,
- Marghitoiu A.-L.,
- Perez L.,
- Nashed-Samuel Y.,
- Anderson C.,
- Vandiver M.,
- Kline S.
- 7.↵
- Parris P.,
- Martin E. A.,
- Stanard B.,
- Glowienke S.,
- Dolan D. G.,
- Li K.,
- Binazon O.,
- Giddings A.,
- Whelan G.,
- Masuda-Herrera M.,
- Bercu J.,
- Broschard T.,
- Bruen U.,
- Callis C. M.,
- Stults C. L. M.,
- Erexson G. L.,
- Cruz M. T.,
- Nagao L. M.
- 8.↵
- Ball D. J.,
- Beierschmitt W. P.
- 9.↵Product Quality Research Institute (PQRI). Safety Thresholds and Best Demonstrated Practices for Extractables and Leachables in Parenteral Drug Products (Intravenous, Subcutaneous, and Intramuscular). 2020. https://pqri.org/wp-content/uploads/2022/03/PQRI-PDP-Recommendation-2022.pdf.
- 10.↵
- Broschard T. H.,
- Glowienke S.,
- Bruen U. S.,
- Nagao L. M.,
- Teasdale A.,
- Stults C. L. M.,
- Li K. L.,
- Iciek L. A.,
- Erexson G.,
- Martin E. A.,
- Ball D. J.
- 11.↵
- Jenke D.
- 12.↵
- Jenke D.,
- Odufu A.
- 13.↵
- Jordi M. A.,
- Rowland K.,
- Liu W.,
- Cao X.,
- Zong J.,
- Ren Y.,
- Liang Z.,
- Zhou X.,
- Louis M.,
- Lerner K.
- 14.↵
- Mullis J. O.,
- Granger A.,
- Quin C.,
- Norwood D. L.
- 15.↵
- Jenke D.,
- Heise T.
- 16.↵
- Jenke D.,
- Liu N.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 4
July/August 2023
Standardization of Chromatographic Screening Methods for Organic Extractables and Leachables by Managing Outcomes
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Jul 2023, 77 (4) 329-338; DOI: 10.5731/pdajpst.2021.012671
Jump to section
Related Articles
- No related articles found.