Nitrosamine

The WHO has published a new draft guideline on considerations for the prevention and control of nitrosamine contamination in pharmaceutical products. This guideline applies to all manufacturers of excipients, active pharmaceutical ingredients and finished pharmaceutical products. The guideline…
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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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PRESS RELEASE February 27, 2024, Asahi Kasei Corp. Contributing to lower risk of potentially carcinogenic nitrosamine impurities in pharmaceuticals To contribute to reducing the risk of potentially carcinogenic nitrosamine impurities in pharmaceuticals and nutritional supplements, Asahi Kasei…
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In summer 2018, drug regulatory authorities first became aware of nitrosamine impurities in a number of medicinal products, including antihypertensives in the sartans class. Trace amounts of nitrosamine impurities were also subsequently detected in other medicinal products. Swissmedic evaluates and…
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N-Nitrosamines are a class of indirect acting mutagens, as their metabolic degradation leads to the formation of the DNA-alkylating diazonium ion. Following up on the in-silico identification of thousands of nitrosamines that can potentially be derived from small molecule drugs and their known…
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N-nitrosamines (NAs) are a class of compounds of which many, especially of the small dialkyl type, are indirect acting DNA alkylating mutagens. Their presence in pharmaceuticals is subject to very strict acceptable daily intake (AI) limits, which are traditionally expressed on a mass basis. Here we…
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See the latest issue of Fuji Chemical Industries Technical Newsletter: It presents Fujicalin®, a low-risk solution for mitigating nitrosamine risks in drug products. Mitigating Nitrosamine Risks in Drug Products: Fuji Chemical Offers a Low-Risk Solution with Fujicalin® Nitrosamine impurities…
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A. FDA Issues notice on “Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities (NDSRIs) and requests comments”. While the FDA’s investigation of the presence of nitrosamine impurities in drug products dates back to June 2018, it was not until more recently that…
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Abstract The onset of the N-nitrosamine (NA) saga in 2018 was chiefly related to certain small dialkyl N-nitrosamines originating from the synthesis of the active pharmaceutical ingredient (API). However, the subsequent comprehensive assessments performed on APIs, formulated drug products, and…
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Abstract The detection of N-nitrosamine impurities in medicines and the recent emergence of nitrosamine drug substance related impurities (NDSRIs) has posed a great challenge to manufacturers of drug products and regulators alike. NDSRIs are primarily associated with reactions occurring in the drug…
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