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Standardization of the Active Pharmaceutical Ingredients Industrial Synthesis Technology

Kushniruk VM, Severina AI and Georgiyants VA

Literature data devoted to the modern principles of the quality assurance and safety of active pharmaceutical ingredients (APIs) industrial synthesis were analyzed. According to the quality by design concept, as well as Green Chemistry Principles, standardized approaches to the API industrial production quality assurance were offered. The main theses concerning development/selection/transfer of substances synthesis technology under pharmaceutical industry conditions were marked. The main criteria for selection a synthesis strategy of chemical substances, initial substances and solvents for the industrial synthesis of APIs were determined. A decision tree when selecting chemicals for their further use in APIs industrial synthesis technology was formulated and constructed. The basic stages and criteria of the process of pharmaceutical development were analyzed, and algorithm of development/transfer of API synthesis technology under industrial conditions, as well as its purification/crystallization was composed. Cause-and-effect diagram concerning the application of the Green Chemistry Principles in the industrial synthesis of APIs was built