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FDA Updates and Press Announcements on Nitrosamines in Rifampin and Rifapentine

FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program:

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 rifampin and rifapentine 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: an LC-MS method for the detection of MNP in rifampin and CPNP in rifapentine drug substance and drug products
  • Complete and submit the report online; or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178
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