An improved, scalable and roboust process for the synthesis of cilastatin sodium: A renal dehydropeptidase inhibitor

Author : Sachin Sonavane, Ravindra Pagire, Dayaghan Patil, Uttam Pujari, Rohan Nikam and Nitin Pradhan

An improved process developed for the synthesis of API, Cilastatin Sodium with more than 99.5% purity and all impurities well below the regulatory limits. The process was specially modified to control the epimeric impurities; solvent purification methods have been developed to achieve desired quality of API without any use of either column chromatography or ion-exchange chromatography.

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