A Review of FDA Requirement on Recommended Acceptable Intake Limits for Nitrosamine Drug Substance Related Impurities
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C Oza
Available at SSRN 5153985, 2025
papers.ssrn.com
… -bupropion, N-nitroso-rifabutin etc. which can be formed in certain conditions due to reaction between nitrites and N-nitroso secondary amines. Hence, … 1500 ng/day N-nitroso-formoterol …

