Controlling Nitrosamine Impurity Levels

The Pharmacopeial Advantage®

In response to the 2018 recall of several Angiotensin II Receptor Blockers (ARBs)* and other products, USP has worked with regulators and industry to develop documentary standards (see prospectus) and a comprehensive portfolio of USP Reference Standards for nitrosamine impurities.

To help companies identify and prevent the occurrence of unacceptable impurities and to support manufacturers and regulators with tools and solutions for testing, assessing risk, and understanding potential sources related to nitrosamine impurities, USP has developed documentary standards (see prospectus) and a comprehensive portfolio of USP Reference Standards for nitrosamine impurities.

These new nitrosamine reference standards can help with your:

  • Trace level quantification of the target impurities
  • Analysis using LC/MS, GC/MS or other suitable techniques
  • Various test methods (FDA, in-house etc.)

Discover the Pharmacopeial Advantage. USP Reference Standards give you the added benefit of globally trusted processes, exceptional service and cost-effective tools that help simplify your work.

*Recalled Angiotensin II Receptor Blockers (ARB) include Valsartan, Losartan, Irbesartan. Other products such as Azilasartan, Olmesartan, Eprosartan, Candesartan, Telmisartan Ranitidine, have been recalled as well.

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