Nitrosamines are categorized as probable carcinogens by the ICH M7 (R1) guideline. Since June 2018, several drugs have been recalled due to the presence of these impurities, in particular the U.S. Food and Drug Administration (FDA) has indicated the presence of a nitrosamine, NDMA, at unacceptable levels in several lots of the extended release formulation of metformin. A transition period of two years has been granted by the regulatory authorities to make changes in manufacturing processes to minimize nitrosamine impurities in finished pharmaceutical products.
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