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Application Note

Highly Selective and Sensitive Method for Quantification of Nitrosamines in Valsartan Drug Substances

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Application Note

Highly Selective and Sensitive Method for Quantification of Nitrosamines in Valsartan Drug Substances

Valsartan and other related “sartan” drugs are frequently used to treat patients with hypertension or heart failure. However, since 2018, hundreds of recalls for sartans have been issued due to contamination with unacceptable levels of nitrosamines, a group of genotoxic compounds. Effective nitrosamine monitoring could help to ensure fewer of these costly product recalls, and unnecessary patient exposure.

Download this app note to discover a method for quantifying nitrosamine levels in sartans that has:

  • A simple sample preparation process
  • High selectivity
  • Detection accuracy of at levels well below current FDA specifications
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