[Elsevier] Simulation of nitrosamine drug substance-related impurities from secondary amine-related impurities in approved human drug products

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journal:Journal of Pharmaceutical Sciences

Authors:Xiang Yu; Jingyue Yang; Ee-Sunn Chia; Tyler Peryea; Dan Berger; Matthew Vera; Tim Marzan; Yen Vu; Diaa Shakleya; David Keire; Andre Raw

Published date:2026-8-

DOI:10.1016/j.xphs.2026.104337

PDF link:https://www.sciencedirect.com/sc ... 022354926001863/pdf

Article link:https://doi.org/10.1016/j.xphs.2026.104337

Article Source:Elsevier BV


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