Supplementary Information Design and Optimization for One Pot Synthesis of Calcium Orotate Using a Quality by Design (QBD) Approach

Abstract

The research focuses on the design and optimization of a one-pot synthesis method for calcium orotate, utilizing a Quality by Design (QbD) approach. Calcium orotate, a compound with significant pharmaceutical and nutraceutical applications, is synthesized through a streamlined process aimed at enhancing efficiency and product quality. The study employs QbD principles to systematically investigate and control various process parameters, ensuring a robust and reproducible method. Through a combination of experimental design, statistical analysis, and risk assessment, key factors influencing the synthesis are identified and optimized. The resulting process not only improves yield and purity but also demonstrates scalability and industrial applicability. This work contributes to the field by providing a comprehensive framework for the rational development of chemical processes, highlighting the benefits of integrating QbD in synthesis strategies.