Nitrosamine in Varenicline particularly Nitroso-varenicline

[Naiffer_Host]

@nitish461990 in the thread below we share the method that FDA published for determination of Nitroso-Varenicline. Have you & team been challenged with this product?

Laboratory analysis of varenicline products by FDA

FDA investigation continues on the presence of N-nitroso-varenicline impurity in varenicline. FDA has also published testing analytical method FY21-092-OTR-DPA-T Determination of Varenicline Nitroso-Drug Substance-Related Impurity in Chantix Drug Product and Drug Substance using LC-ESI-HRMS.pdf (166.1 KB) [image] Agency scientists evaluated the risk of exposure to N-nitroso-varenicline at interim acceptable intake levels up to 185 ng per day (92.5 ppm) and determined that it presents minimal…