1. Guidance for Industry Revision 1,2021
2. Is this the end for ranitidine? NDMA presence continues to confound;Wagner;Clin Transl Sci,2021
3. Ranitidine-investigations into the root cause for the presence of NNitrosoN,Ndimethylamine in ranitidine hydrochloride drug substances and associated drug products;King;Org Process Res Dev,2020
4. A nitrite excipient database: a useful tool to support N-Nitrosamine risk assessments for drug products;Boetzel;J Pharm Sci,2022
5. Lhasa limited, Nitrites in excipient database. Available athttps://www.lhasalimited.org/news/nitrites-in-excipients-data-release-supporting-more-scientifically-driven-nitrosamine-risk-assessments/11537. Accessed November 9, 2022