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Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation

Risk control for nitrosamine impurities in drug products is currently a major challenge in the industry. Nitrosamines can form during drug product manufacturing and storage through the reaction of nitrites with amine-containing APIs or impurities. The level of nitrites in excipients and the rate of...

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Detalles Bibliográficos
Autores principales:	Berardi, Alberto, Jaspers, Maarten, Dickhoff, Bastiaan H. J.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	MDPI 2023
Materias:	Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10458871/ https://www.ncbi.nlm.nih.gov/pubmed/37631229 http://dx.doi.org/10.3390/pharmaceutics15082015

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