A group of researchers have created a new, quick way to check for harmful substances called nitrosamines in the main active parts of medicines, known as APIs. This method uses a technique called nuclear magnetic resonance (NMR) spectroscopy. The new approach combines a test called the nitrosation assay procedure (NAP) with special ingredients and NMR spectroscopy. It helps overcome the problems of older methods that rely on mass measurements, according to Simonetto and his team. The study was started because of a rule that requires checking for nitrosamine risks in the API dexlansoprazole. When this API is under stress, it can change in a way that might create unexpected nitrosamines, which are not usually found in standard tests. The researchers wanted to see if the structure of dexlansoprazole could lead to the formation of nitrosamines. The new test can tell the difference between similar molecules and breakdown products. It also acts as a quick test to see if a molecule is likely to form nitrosamines. If there are no signs of nitrosamines in the test, then the molecule is not likely to form them. Gabriele Razzetti, the Global Director of R&D at Dipharma Francis S.r.l., said: “Thanks to our new approach, we can confirm or rule out the formation of nitrosamines with great clarity, even in the most complex situations.” This includes difficult cases, added Razzetti. “This combined approach gives us a strong and quick tool for checking nitrosamine risks and helps us follow the rules by confirming or ruling out nitrosamine formation when the API is under stress.” The new technique could be very useful for checking nitrosamine formation during the development and manufacturing of APIs. It supports understanding impurities, the manufacturing process, and following the latest rules. The method was developed by Dipharma Francis S.r.l., a company that helps develop and manufacture APIs. The research was published in the journal Organic Process Research & Development.