According to recent guidance published by both the FDA and EMA, nitrosamines and NDSRIs must be monitored at the low ng/mL level using highly sensitive analytical methodologies. LC-MS/MS is inherently a selective and sensitive analytical technique that is well-suited for identification and quantification of nitrosamines at very low levels.

In this presentation, we cover the accurate determination and quantitation of nitrosamine impurities and NDSRIs in drug substances and products using LC-MS/MS based analytical strategies that can readily be adopted.

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