FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Warns Against High-Temperature Test for NDMA in Ranitidine Drugs

Oct. 15, 2019
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The FDA warned manufacturers of ranitidine products not to use a high-temperature test for N-Nitrosodimethylamine (NDMA) because it actually generates high levels of the impurity.

The agency noted that an unnamed third-party laboratory used the test and reported very high NDMA levels.

The FDA instead recommends using an LC-HRMS testing protocol to test ranitidine samples because it does not use elevated temperatures and has shown much lower levels of NDMA than reported by the laboratory. International regulators using similar testing methods to LC-HRMS have also found lower NDMA levels in ranitidine samples.

Manufacturers should either use the LC-HRMS method to conduct their own tests, or send samples to the FDA for testing, the agency said.

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