Article CommentaryCommentary
Identification and Quantitation Classifications for Extractables and Leachables
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 275-285; DOI: https://doi.org/10.5731/pdajpst.2019.010538
Dennis Jenke
Triad Scientific Solutions, LLC, Hawthorn Woods, IL, USA

References
- 1.↵Biological Evaluation of Medical Devices—Part 18: Chemical Characterization of Medical Device Materials Within a Risk Management Process. Association for the Advancement of Medical Instrumentation (AAMI): Arlington, VA, 2020.
- 2.↵
- Jenke D.
- 3.↵U.S. Pharmacopeial Convention, General Chapter <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems. In USP 41/NF 36, USP: Rockville, MD, 2018; pp 7910–7923.
- 4.↵
- Christiaens P.,
- Beusen J. M.,
- Verlinde P.,
- Baeten J.,
- Jenke D.
- 5.↵
- Ball D. J.,
- Norwood D. L.,
- Stults C. L. M.,
- Nagao L. M.
- Norwood D. L.,
- Mullis J. O.,
- Pennino S. J.
- 6.↵
- Mullis J. O.,
- Granger A.,
- Quinn C.,
- Norwood D. L.
- 7.↵
- Jenke D.,
- Odufu A.
- 8.↵
- Zdravkovic S. A.,
- Duong C. T.,
- Hellenbrand A. A.,
- Duff S. R.,
- Dreger A. L.
- 9.↵
- Jenke D.,
- Liu N.
- 10.↵
- Jordi M. A.,
- Khera S.,
- Roland K.,
- Jiang L.,
- Solomon P.,
- Nelson J.,
- Lateef S. S.,
- Woods J.,
- Martin L.,
- Martin S.,
- Aiello F.,
- Chen N.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 2
March/April 2020
Identification and Quantitation Classifications for Extractables and Leachables
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 275-285; DOI: 10.5731/pdajpst.2019.010538
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