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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.
Mercea PV, Ossberger M, Wyrwich R, Herburger M, Barge VJ, Aluri R, Tosa V. Mercea PV, et al. PDA J Pharm Sci Technol. 2023 Aug 14:pdajpst.2022.012817. doi: 10.5731/pdajpst.2022.012817. Online ahead of print. PDA J Pharm Sci Technol. 2023. PMID: 37580130
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 1: Experimental details and modeling experimental results.
Mercea PV, Ossberger M, Wyrwich R, Herburger M, Barge VJ, Aluri R, Tosa V. Mercea PV, et al. PDA J Pharm Sci Technol. 2023 Aug 14:pdajpst.2022.012816. doi: 10.5731/pdajpst.2022.012816. Online ahead of print. PDA J Pharm Sci Technol. 2023. PMID: 37580127