Now also realising that possibly the HC RAIL change on N-nitroso-sertraline is linked to the FDA Ames test results reported in May 2024: N-nitroso-sertraline is uniquely positive in E. coli WP2 uvrA (pKM101), only with the use of hamster S9 (10% and 30%) in these tests.
Fiscal Year (FY) 2024 Generic Drug Science and Research Initiatives Public Workshop. Presentation “N-Nitrosamine Drug Impurity Research at FDA/NCTR: Assessing the Mutagenicity of N-Nitrosamines and NDSRIs” - Xilin Li, PhD, Visiting Scientist, DGMT, NCTR, FDA. https://www.fda.gov/media/177881/download