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  1. Drug Safety and Availability

FDA Updates and Press Announcements on NDMA in Metformin

FDA-published testing method to provide an option for regulators and industry to detect NDMA impurities
The links below are to FDA-published testing methods to provide an option for regulators and industry to detect nitrosamine impurities in metformin drug substances and drug products. These methods 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 metformin drug substance and drug products.
  • LC-ESI-HRMS method: an LC-HRMS method for the measurement of amounts of eight nitrosamine impurities in metformin drug substance and drug products

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