September 9, 2026

API manufacturers spend years developing a synthesis route. That route contains process steps, impurity controls, and material specifications that competitors would love to copy. At the same time, the FDA needs to see all of that detail before it lets a drug reach patients. These two needs pull in opposite directions, and the drug master […]

You spend weeks purifying a compound to 99% ee, and if storage conditions are wrong, that single enantiomer slides back toward a 50:50 mixture within days. That process is racemization, the conversion of an optically active compound into a racemic mixture, along with the loss of optical activity. The molecule doesn’t disappear and no bonds