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

Authors

  • Sachin Sonavane Wanbury Ltd, R&D Center, EL-16, TTC Industrial Area MIDC, Mahape, Navi Mumbai - 400 710, Maharashtra, India
  • Ravindra Pagire Wanbury Ltd, R&D Center, EL-16, TTC Industrial Area MIDC, Mahape, Navi Mumbai - 400 710, Maharashtra, India
  • Dayaghan Patil Wanbury Ltd, R&D Center, EL-16, TTC Industrial Area MIDC, Mahape, Navi Mumbai - 400 710, Maharashtra, India
  • Uttam Pujari Wanbury Ltd, R&D Center, EL-16, TTC Industrial Area MIDC, Mahape, Navi Mumbai - 400 710, Maharashtra, India
  • Rohan Nikam Wanbury Ltd, R&D Center, EL-16, TTC Industrial Area MIDC, Mahape, Navi Mumbai - 400 710, Maharashtra, India
  • Nitin Pradhan Wanbury Ltd, R&D Center, EL-16, TTC Industrial Area MIDC, Mahape, Navi Mumbai - 400 710, Maharashtra, India

Keywords:

Cilastatin Sodium, Epimeric Impurities, Solvent Purification, Column Chromatography, Ion-exchange Chromatography

Abstract

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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Published

2017-09-02

How to Cite

Sachin Sonavane, Ravindra Pagire, Dayaghan Patil, Uttam Pujari, Rohan Nikam, & Nitin Pradhan. (2017). An improved, scalable and robust process for the synthesis of cilastatin sodium: A renal dehydropeptidase inhibitor . World Journal of Pharmaceutical Sciences, 5(9), 271–278. Retrieved from https://wjpsonline.com/index.php/wjps/article/view/improved-scalable-synthesis-cilastatin-sodium

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Section

Research Article

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