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Autor:
Ruth Boetzel, Joerg Schlingemann, Sebastian Hickert, Christian Korn, Grace Kocks, Bert Luck, Giorgio Blom, Mark Harrison, Marc François, Leonardo Allain, Yongmei Wu, Youssi Bousraf
Publikováno v:
Journal of Pharmaceutical Sciences. 112:1615-1624
N-Nitrosamine risk assessment and control have become an integral part of pharmaceutical drug product development and quality evaluation. Initial reports of nitrosamine contamination were linked with the drug substance and its manufacturing process.