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FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)

QA on NDMA in ranitidine

FDA-published testing method to provide an option for regulators and industry to detect NDMA impurities
The link below is to an FDA-published testing method to provide an option for regulators and industry to detect nitrosamine impurities in ranitidine 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-HRMS method: an LC-MS method for the detection of NDMA in ranitidine drug substance and drug products
  • LC-MS/MS method: An alternative method for the detection of NDMA in ranitidine drug substance and drug products. This method is based on a triple-quadrupole MS platform.