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1

Accumulation of organic compounds leached from plastic materials used in biopharmaceutical process containers.

Jenke DR, Zietlow D, Garber MJ, Sadain S, Reiber D, Terbush W. Jenke DR, et al. PDA J Pharm Sci Technol. 2007 Jul-Aug;61(4):286-302. PDA J Pharm Sci Technol. 2007. PMID: 17933210

2

Accumulation of extractables in buffer solutions from a polyolefin plastic container.

Jenke DR, Jene JM, Poss M, Story J, Tsilipetros T, Odufu A, Terbush W. Jenke DR, et al. Int J Pharm. 2005 Jun 13;297(1-2):120-33. doi: 10.1016/j.ijpharm.2005.03.010. Int J Pharm. 2005. PMID: 15907599

3

Extractables/leachables from plastic tubing used in product manufacturing.

Jenke DR, Story J, Lalani R. Jenke DR, et al. Int J Pharm. 2006 Jun 6;315(1-2):75-92. doi: 10.1016/j.ijpharm.2006.02.011. Epub 2006 Mar 6. Int J Pharm. 2006. PMID: 16563675

4

A consideration of the impact of solution composition on the accumulation of organic substances leached from plastics used in container/closure systems.

Jenke D, Couch T. Jenke D, et al. PDA J Pharm Sci Technol. 2006 Jan-Feb;60(1):60-71. PDA J Pharm Sci Technol. 2006. PMID: 17089679

5

Extractable/leachable substances from plastic materials used as pharmaceutical product containers/devices.

Jenke D. Jenke D. PDA J Pharm Sci Technol. 2002 Nov-Dec;56(6):332-71. PDA J Pharm Sci Technol. 2002. PMID: 12497770 Review.

6

Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products.

Jenke D, Egert T, Hendricker A, Castner J, Feinberg T, Houston C, Hunt DG, Lynch M, Nicholas K, Norwood DL, Paskiet D, Ruberto M, Smith EJ, Holcomb F, Markovic I. Jenke D, et al. PDA J Pharm Sci Technol. 2017 Mar-Apr;71(2):68-87. doi: 10.5731/pdajpst.2016.007229. Epub 2016 Dec 14. PDA J Pharm Sci Technol. 2017. PMID: 27974627

7

The effect of solvent polarity on the accumulation of leachables from pharmaceutical product containers.

Jenke D, Odufu A, Poss M. Jenke D, et al. Eur J Pharm Sci. 2006 Feb;27(2-3):133-42. doi: 10.1016/j.ejps.2005.09.001. Epub 2005 Oct 24. Eur J Pharm Sci. 2006. PMID: 16246534

8

Development of an HPLC/UV method for the evaluation of extractables and leachables in plastic: Application to a plastic-packaged calcium gluconate glucoheptonate solution.

Legrand P, Desdion A, Boccadifuoco G, Dufaÿ Wojcicki A, Worsley A, Boudy V, Dufay SG. Legrand P, et al. J Pharm Biomed Anal. 2018 Jun 5;155:298-305. doi: 10.1016/j.jpba.2018.03.044. Epub 2018 Mar 21. J Pharm Biomed Anal. 2018. PMID: 29679874

9

Development and Justification of a Risk Evaluation Matrix To Guide Chemical Testing Necessary To Select and Qualify Plastic Components Used in Production Systems for Pharmaceutical Products.

Jenke D. Jenke D. PDA J Pharm Sci Technol. 2015 Nov-Dec;69(6):677-712. doi: 10.5731/pdajpst.2015.01077. PDA J Pharm Sci Technol. 2015. PMID: 26659101

10

Introducing the Alba® Primary Packaging Platform. Part 2: Inorganic Extractables Evaluation.

Chillon A, Zuccato D. Chillon A, et al. PDA J Pharm Sci Technol. 2019 May-Jun;73(3):235-246. doi: 10.5731/pdajpst.2018.009423. Epub 2019 Jan 16. PDA J Pharm Sci Technol. 2019. PMID: 30651335

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