Project challenge: Seven stage sequence involving protection-deprotection sequence, labile intermediates and signicant by-product formation with low yield. Solution design: Salient features of the approach: Route scouting to come up with a new route that furnished the NCE in three chemical conversions, thus reducing the cycle time of development of NCE Identication of suitable protecting groups and deprotecting reagents and reaction conditions to optimize the yield Route developed was implemented in manufacturing plant and process validation performed
Effective purication techniques including crystallization resulted in control of unknown impurities and generated quality product, meeting ICH specications Conclusion: This case study exemplies the technical abilities of our team in route scouting and developing a process that can be implemented on scale and creating value to the customer in terms of cost and time.
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