Process Development Situation: Route identified by customer run at lab scale earlier and has significant processing and scale up issues in form of purity of product as well as workup of the stages involved.
Solution: Process development while retaining original route involved:
Optimization of catalyst loading to obtain reaction completion and reduction in impurity formation.
Development of reaction monitoring method to help in process optimization
Change method of catalyst loading from wet catalyst (methanol washed) to dry catalyst to improve safety of process
Change of crystallization solvent to improve process yield and crystal habit
Product obtained as a crystal powder vs. waxy solid, thereby enabling efficient scale up.
Result: Establishment of safer and scalable process up to 200 Kg batch sizes with significant improvement in yield and product quality.
