Nitrosamine

1. Introduction The issue of Nitrosamine impurities in drug and excipient manufacturing has become a significant concern for the pharmaceutical industry and health authorities. In June 2018, the FDA was notified of the presence of N-nitrosodimethylamine (NDMA), an impurity found in valsartan, an…
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N-nitrosamines are likely human carcinogens. After N-nitrosamine contaminants were detected in pharmaceutical products in 2018, regulatory authorities set a framework for the risk assessment, testing and mitigation of N-nitrosamines in drug products. One strategy to inhibit the formation of …
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USP has launched the newest tool in their suite of solutions to address the evolving nitrosamines crisis: the Nitrosamines Analytical Hub, a public, web-based repository of downloadable analytical procedures to test for nitrosamine impurities and related substances in pharmaceuticals. In recent…
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The potential for active pharmaceutical intermediates and active ingredients to contain low levels of N-nitrosamines is a topic of continued interest from industry and regulatory authorities, which has led us to generate experimental data demonstrating that the published kinetic model of…
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Many nitrosamines have been recognized to be carcinogenic for many decades. Despite the fact that several nitrosamine precursors are frequently used in the manufacturing of pharmaceutical products, their potential presence in pharmaceutical products has previously been overlooked due to a lack of…
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In mid-2018, N-nitroso-dimethylamine (NDMA) was unexpectedly detected in a valsartan active pharmaceutical ingredient (API). NDMA, like many other nitrosamines, is mutagenic and a probable human carcinogen. In contrast to many other newly discovered impurities, the observation of nitrosamines in…
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The European Medicines Agency, the U.S. Food and Drug Administration, and other regulatory agencies expect that all pharmaceutical products be assessed for the potential presence of N-nitrosoamine (nitrosamine) impurities. This white paper addresses general considerations for nitrosamine risk…
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Since late 2019, concerns regarding trace levels of the probable human carcinogen N-dimethylnitrosamine (NDMA) in Metformin-containing pharmaceuticals have been an issue if they exceeded the maximum allowable intake of 96 ng/day for a medicine with long-term intake. Here, we report results from an…
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INTRODUCTION The effects of N-nitroso compounds on human health (particularly their role in gastric cancer) are well known.1 Certain N-nitrosamines are described as highly probable human carcinogens. They are usually formed by the reaction of secondary or tertiary amines with a source of a…
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This article reports the outcome of an in silico analysis of more than 12,000 small molecule drugs and drug impurities, identifying the nitrosatable structures, assessing their potential to form nitrosamines under relevant conditions and the challenges to determine compound-specific AIs based on…
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