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Bereich: Suchergebnisse
Publikation Modeling-Based Approach Towards Quality by Design for a Telescoped Process(Hochschule für Life Sciences FHNW, 2022) Zogg, Andreas; Zahnd, This; Zogg, Andreas; Siegfried AGA synthesis step, consisting of two sub-steps A and B was investigated by applying a model based approach. Deepening the process understanding was achieved through performed experiments, which also led to the generation of valuable knowledge for future improvements. A kinetic model consisting of 12 reactions and 15 components was successfully established. The model predicts the effects of changes in process parameters on quality. On this basis recommendations for process optimizations have been formulated.11 - Studentische ArbeitPublikation Nitrosamine formation and scavenging in drug products(Hochschule für Life Sciences FHNW, 2022) Ammon-Kircher, Tamara; Zogg, Andreas; NovartisNitrosamines are considered potential mutagens in the absence of toxicological data and need to be controlled in nanogram quantities in medicinal products. In the case that a medicinal product contains a primary source of vulnerable amines, it would be desirable to have an inhibitor (nitrite scavenger) of nitrosamine formation that can be added to a formulation. Wet granulation has been identified as a critical process step in drug manufacture, this was simulated in this work.The nitrosamine formation was monitored using two systems. On the one hand, an HPLC UV/VIS analysis was implemented to monitor the nitrite level, on the other hand the nitrosamine content was detected using a Triple Quadrupole LC/MS analysis. The rate constant of nitrosation was obtained by regression of measured nitrite concentrations. Based on the results, the nitrite decomposition in water at different pH and temperature should be modelled in a mathematical model like MatLab11 - Studentische Arbeit