Angiotensin-receptor blockers (ARBs) or sartans are among the most widely-used medicines for hypertension and heart failure. A lot of commotion has been raised recently over the problem of successive global recalls of several generic preparations of ARBs because of carcinogenic impurities (three substances discovered to date: NDMA, NDEA and NMBA) detected initially in valsartan products by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and which issued recall orders, while other authorities followed closely with similar recalls.
The FDA have released testing methods to provide options for regulators and industry to detect nitrosamine impurities in ARB drug substances and drug products.
Thermo Fisher Scientific is one of the leading manufacturer of mass spectrometry instruments and has optimized and validated these methods on Thermo Scientific GCMS and LCMS systems. These methods met all the requirements of current regulations, sensitivity and repeatability exceeded the expected requirements of the control limits. Consequently delivering consistent results longer and achieve higher sample throughput with almost no downtime, making these analytical systems especially suitable for the detection of trace genotoxic impurities in complex drug matrix.
The first-part of this webinar series examines the global issues surrounding the Nitrosamine impurities and how Thermo Fisher Scientific instruments can help. Fill in the form to find out more and stay tuned to second part of this webinar series.
