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Saturday, 28 March 2020

Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities


Angiotensin-receptor blockers (ARBs) or sartans are among the most widely used medicines for hypertension and heart failure. After nitrosamine impurities were discovered in valsartan by the US FDA & EMA, the industry saw several costly global recalls by various global regulatory authorities. The US FDA and EMA have recommended that manufacturers of ARBs (sartans) review their manufacturing processes so that they do not produce nitrosamine impurities and after a transition period with very strict limits on the levels of these impurities, their generic sartans should contain no quantifiable levels of these impurities.

Sartanimpurities_whitepaper

How impurities came to be present in sartans

Before June 2018, NDMA and NDEA were not among the impurities identified in sartan medicines and were therefore not detected by routine tests.

It is now known that these impurities can form during the production of sartans that contain a specific ring structure known as a tetrazole ring under certain conditions and when certain solvents, reagents, and other raw materials are used. In addition, it is possible that impurities were present in some sartans because manufacturers had inadvertently used contaminated equipment or reagents in the manufacturing process.

Companies must now take measures to avoid the presence of these impurities and carry out rigorous testing of their products.

Objective : Need for robust and highly sensitive analytical solutions to detect Sartan impurities

Determine genotoxic nitrosamines in ARB class of drugs with gas chromatography and mass spectrometry techniques

The Thermo Scientific™ TSQ™ 9000 triple quadrupole GC-MS/MS system can detect trace levels of these genotoic impurities in complex drug matrices while meeting all the sensitivity and repeatability requirements of current regulations and exceeding the requirements of the much stricter control limits expected in the near future.

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