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Can I read N-nitrosamine Mitigation with Nitrite Scavengers in Oral Pharmaceutical Drug Products on EtoBox?
N-nitrosamine Mitigation with Nitrite Scavengers in Oral Pharmaceutical Drug Products by Anne-Cécile V. Bayne; Zdravka Misic; René T. Stemmler; Marc Wittner; Margarita Frerichs; Julia K. Bird; Ahmed Besheer is a Chemistry article available to read on EtoBox.
What is N-nitrosamine Mitigation with Nitrite Scavengers in Oral Pharmaceutical Drug Products about?
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 N-nitrosamines during the manufacture and storage of drug products involves the incorporation of nitrite scavengers in the formulation. Diverse molecules have been tested in screening studies including the antioxidant vitamins ascorbic acid and α-tocopherol, amino acids, and other antioxidants used in foods or drugs, for inclusion into drug products to mitigate N-nitrosamine formation. This review article outlines key considerations for the inclusion of nitrite scavengers in oral drug product formulations.
Who reads N-nitrosamine Mitigation with Nitrite Scavengers in Oral Pharmaceutical Drug Products?
It is typically read by researchers, students, and practitioners in Chemistry.
- Author
- Anne-Cécile V. Bayne; Zdravka Misic; René T. Stemmler; Marc Wittner; Margarita Frerichs; Julia K. Bird; Ahmed Besheer
- Publisher
- Elsevier BV
- Published
- 2023
- Language
- EN
- Field
- Chemistry (Physical Sciences)