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Development of a platform for the synthesis and analytical certification of nitrosamines of pharmaceutical interest

Abstract

The identification and quantification of impurities in the production process, or even resulting from the stability of drugs and medicines, comprise an extremely important stage of the drug research and development process. In this context, one of the factors that greatly impacted pharmaceutical laboratories in recent years was the need to comply with Anvisa's RDC No. 53/2015, which regulates procedures for notification, identification and qualification of impurities and drug degradation products. It is known that the synthesis of a process impurity or degradation product can be a very complex activity, which requires time and, especially, a team of experienced and highly qualified synthetic chemists, which most pharmaceutical laboratories do not have. Thus, national industries seek mostly in the international market, analytical standards of companies specialized in the preparation of these compounds. However, in addition to normally having a high cost, the import acquisition process takes time and suffers from frequent delays, facts that can hinder the compliance with deadlines for analytical documentation and product registration with Anvisa. Considering this scenario, as well as the small number of national companies that dedicate themselves to synthesis on demand, Avita identified a clear market niche that is still not very competitive at national and continental levels. The strong demand highly specialized by pharmaceutical standards, even, brought the need to adapt to the company's business model, which had as its initial focus only the synthesis of Active Pharmaceutical Ingredients. Guided by this new business model, the company has developed, in recent years, projects for the synthesis of impurities and degradation products in partnership with major national pharmaceutical companies. With the maintenance of the focus on innovation, as well as the constant search to reduce the environmental impacts of the processes used in the company, the new business model can be defined as "Long Tail", as it focuses on offering the pharmaceutical market a line of niche products, with high added value, and it is intended to keep products in stock, aiming at prompt service to the market. Therefore, we chose nitrosamines as a starting point, as we received several inquiries from pharmaceutical laboratories regarding the possibility of supplying these compounds, aiming at meeting the requirements of RDC No. 283/2019 and information note No. 1/20 of Anvisa, which recommends control and elimination of potentially carcinogenic nitrosamines in drugs. (AU)

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