N-NITROSAMINES AS THE MAIN IMPURITY FOUND IN MEDICINES: A NARRATIVE REVIEW

Abstract

N-nitrosamines represent a group of chemical compounds that have been identified as impurities of concern in medicines. These substances are known for their carcinogenic potential and, therefore, have attracted great attention in the pharmaceutical industry and among national and international regulatory agencies. N-nitrosamines can form during processes of obtaining the active pharmaceutical ingredient (IFA), manufacturing and storage of medicines, especially when there is the presence of precursors, such as secondary amines and nitrites. In order to correctly control these inputs, it is necessary to include regulatory measures, including the review and optimization of formulations, synthesis processes and analytical methods to ensure compliance with regulatory standards. Corroborating these practices, we sought to carry out a narrative bibliographic review study with the aim of providing information and supporting other studies by preparing a compilation of information and highlighting the importance of quality control and regulatory agencies in the production of safe and effective medicines. . Continuous control and monitoring of the presence of N-nitrosamines in medicines is essential to ensure patient safety and the quality of pharmaceutical products. The theme highlights the importance of collaboration between industry, regulatory agencies and other interested parties to face this complex challenge and ensure the integrity of medicines available on the market.