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Saudi Journal of Medical and Pharmaceutical Sciences (SJMPS)
Volume-11 | Issue-05 | 354-359
Review Article
Emerging Perspectives on Nitrosamine Impurities in Pharmaceuticals: Risks, Regulatory Frame Works, and Mitigation Strategies
Ashok Gorja, Madhavi Molgara, Preethi Medala, Amulya Sirra, Gajjagouni Meghana Goud, Durga Panikumar Anumolu
Published : May 5, 2025
DOI : https://doi.org/10.36348/sjmps.2025.v11i05.001
Abstract
N-nitrosamines are carcinogenic impurities most commonly found in groundwater, treated water, foods, beverages and consumer products. The recent discovery of N-nitrosamines in pharmaceutical products and subsequent recalls pose a significant health risk to patients. Initial investigation by the regulatory agency identified Active Pharmaceutical Ingredients (API) as a source of contamination. However, N-nitrosamine formation during API synthesis is a consequence of numerous factors like chemistry selection for synthesis, contaminated solvents and water. Furthermore, apart from API, N-nitrosamines have also been found to embed in the final product due to degradation during formulation processing or storage through contaminated excipients and printing inks. The landscape of N-nitrosamine contamination of pharmaceutical products is very complex and needs a comprehensive compilation of sources responsible for N-nitrosamine contamination of pharmaceutical products. Therefore, this review aims to extensively compile all the reported and plausible sources of nitrosamine impurities in pharmaceutical products. The topics like risk assessment and quantitative strategies to estimate nitrosamines in pharmaceutical products are out of the scope of this review.
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