Evaluating nitrosamines from elastomers in pharmaceutical primary packaging
B Boltres - PDA Journal of Pharmaceutical Science and …, 2022 - journal.pda.org
Nitrosamines have gained unexpected attention again, triggered by their discovery at
significant concentrations in some active pharmaceutical ingredients and pharmaceutical …
significant concentrations in some active pharmaceutical ingredients and pharmaceutical …
An investigation to examine the effect of the elastomeric surface treatment on protein stability
R Singh, L Waxman, L Fang, C Zhao - PDA Journal of …, 2021 - journal.pda.org
Various kinds of treatments on the surface of the elastomeric components can have negative
impacts on the quality of protein therapeutics. We compared the effects of bare (non …
impacts on the quality of protein therapeutics. We compared the effects of bare (non …
Modeling the Migration Behavior of Extractables from Mono-and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in …
PV Mercea, M Ossberger, R Wyrwich… - PDA journal of …, 2024 - journal.pda.org
In the development of a pharmaceutical drug product packaging, an important step is to
demonstrate acceptable levels of leachable impurities migrating from the packaging material …
demonstrate acceptable levels of leachable impurities migrating from the packaging material …