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FDA Updates and Press Announcements on Nitrosamine in Varenicline (Chantix)

FDA-published testing method to provide an option for regulators and industry to detect nitrosamine impurities
The link below is to an FDA-published testing method to provide an option for regulators and industry to detect nitrosamine impurities in varenicline drug substances and drug products. This method should be validated by the user if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission.
  • LC-ESI-HRMS method: A reverse phase LC method with HRMS detection for the determination of varenicline NDSRI in Chantix™ drug product or drug substance.

 

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