Accès ouvert
2026
article
OpenAlex
Rok Grahek, Simona Peterlin, Monika Malovrh, Pia Repše et autres
Nitrites in pharmaceutical excipients are a known critical factor for the formation of nitrosamine impurities. The origin and variability of nitrite levels are, however, not yet fully understood. In this study, we investigated the formation and uptake of nitrite in a broad …
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Accès ouvert
2026
article
OpenAlex
Peter Ritzler, Holger Bauer, Michael Burns, Brunhilde Guessregen et autres
High Resolution Image Download MS PowerPoint Slide The recovery of solvents in pharmaceutical manufacturing offers substantial sustainability benefits but raises concerns about the potential carryover of mutagenic impurities, particularly N- nitrosamines (hereinafter: nitrosamines). This study presents a validated, comprehensive framework for in-silico …
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Accès ouvert
2026
article
OpenAlex
Rok Grahek, Renat Selimov, Miha Drev, Holger Bauer et autres
Atmospheric nitrogen oxides (NO x ) have emerged as a potential contributor to nitrosamine formation in active pharmaceutical ingredients (APIs) containing vulnerable amines. This study investigates the extent and mechanisms of NO x -mediated nitrosation under controlled conditions and evaluates its relevance …
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