Drug substance development necessitates a scalable and stable biological or chemical process to manufacture the drug before commercialization . For biologics, such as RNA, peptide, and antibody-based drugs, cell-based processes are used for manufacturing . Small molecule drugs are synthesized through a set of chemical reactions, where initial reactions focus on making the different motifs in the drug molecule, and the reaction products come together in the final steps to complete the intended molecule . As can be noted from the complexity of the reaction scheme in the small molecule synthesis, the by-products of individual reactions create impurities, and these impurities can propagate through, from step to step, to the final drug substance, if not identified and controlled via reaction optimization or purification operations . Thus, chemical process development, involving identification, development, optimization, and scale-up of chemical synthetic routes, is a major activity required in the commercialization of small molecule drug substances .