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Modeling the migration behaviour of extractables from mono- and multi-layer polyolefin films to mathematically predict the concentration of leachable impurities in pharmaceutical drug products. Part 2: Conservative diffusion and partition coefficient determinations
Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal J Barge, Rajendra Aluri and Valer Tosa
PDA Journal of Pharmaceutical Science and Technology August 2023, pdajpst.2022.012817; DOI: https://doi.org/10.5731/pdajpst.2022.012817
Peter V. Mercea
1 FABES GmbH;
Manfred Ossberger
1 FABES GmbH;
Regina Wyrwich
1 FABES GmbH;
Matthias Herburger
1 FABES GmbH;
Vishal J Barge
2 Pfizer Inc.;
Rajendra Aluri
2 Pfizer Inc.;
Valer Tosa
3 National Institute for Research and Development of Isotopic and Molecular Technologies, Cluj-Napoca / Romania
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 5
September/October 2023
Modeling the migration behaviour of extractables from mono- and multi-layer polyolefin films to mathematically predict the concentration of leachable impurities in pharmaceutical drug products. Part 2: Conservative diffusion and partition coefficient determinations
Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal J Barge, Rajendra Aluri, Valer Tosa
PDA Journal of Pharmaceutical Science and Technology Aug 2023, pdajpst.2022.012817; DOI: 10.5731/pdajpst.2022.012817
Modeling the migration behaviour of extractables from mono- and multi-layer polyolefin films to mathematically predict the concentration of leachable impurities in pharmaceutical drug products. Part 2: Conservative diffusion and partition coefficient determinations
Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal J Barge, Rajendra Aluri, Valer Tosa
PDA Journal of Pharmaceutical Science and Technology Aug 2023, pdajpst.2022.012817; DOI: 10.5731/pdajpst.2022.012817
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