Nitrosamine Impurity Detection And Quantification In Sartans And Ranitidine

In response to rising global concerns about nitrosamine contamination in pharmaceutical products, Aragen has developed and validated highly sensitive methods for detecting and quantifying these potentially carcinogenic impurities, including NDMA and NDEA, in critical medications such as Sartans and Ranitidine. This issue came into sharp focus when, in 2018, the U.S. FDA identified nitrosamine impurities in several Angiotensin II Receptor Blocker (ARB) drugs, prompting multiple product recalls and raising significant regulatory scrutiny. Since then, nitrosamine contamination has extended to other medicines such as Ranitidine, prompting urgent calls for robust detection protocols.

Solution Labs have had to respond decisively by adopting and implementing USFDA-recommended methods, utilizing LC-HRMS (Orbitrap) and LC-MS, which are capable of detecting nitrosamines at parts-per-billion levels under R&D conditions. These services also extend to a broad spectrum of analytical capabilities, including genotoxic impurity analysis, physicochemical characterization, and stability studies. With advanced instrumentation and a scientifically rigorous approach, Aragen provides a vital line of defense in ensuring pharmaceutical safety and compliance. Learn how these solutions can help your organization stay ahead of nitrosamine regulations.