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DEVELOPMENT OF A PLATFORM FOR SYNTHESIS AND ANALYTICAL CERTIFICATION OF PHARMACEUTICAL IMPURITIES

Abstract

Pharmaceutical impurities are unwanted chemicals present in pharmaceutical products. In finished products, their origin can be related both to their presence in the aforementioned inputs used in the manufacturing process, and to their development during the product formulation, in the packaging process or with its aging (degradation). In recent decades, the modernization of pharmaceutical processes has been accompanied by an increase in product quality requirements, making the control of pharmaceutical impurities a constant concern, both in companies and in regulatory agencies. Even with all this control, the recent detection of potentially carcinogenic nitrosamines in batches of drugs from the sartan class culminated in the mass recall of these drugs from pharmacies and laboratories around the world, bringing to light the need to control these pharmaceutical impurities. In Brazil, this incident had an immediate impact, resulting in the publication of RDC 283/2019 by ANVISA, which provides for the investigation, control and elimination of nitrosamines in angiotensin II receptor antagonists, which was later expanded to all classes of drugs. Thus, based on the great importance of these compounds, the objectives of this project are based on the development of a platform for the synthesis and analytical certification of non-classical nitrosamines, using protocols in batches and in continuous flow reactors, as well as the development of analytical methods that allow the determination of the purity of such compounds aiming at both future toxicological evaluations and their use as Characterized Reference Chemical Substances (SQC). In addition, the platform to be developed will be applied directly to commercial drugs, in order to characterize and evaluate the structural features of several potentially toxic impurities for which there are still no data reported in the literature. (AU)

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