Application of On-Line NIR for Process Control during the Manufacture of Sitagliptin
George Zhou*, Shane Grosser, Lei Sun, Gabriel Graffius, Ganeshwar Prasad, Aaron Moment, Angela Spartalis,Paul Fernandez, John Higgins, Busolo Wabuyele, and Cindy Starbuck
Global Science, Technology and Commercialization, Merck Sharp & Dohme Corporation P.O. Box 2000, Rahway, New Jersey 07065, United States
Org. Process Res. Dev., 2016, 20 (3), pp 653–660
DOI: 10.1021/acs.oprd.5b00409
Publication Date (Web): February 12, 2016
Copyright © 2016 American Chemical Society
*E-mail: george_zhou@merck.com.
Abstract
The transamination-chemistry-based process for sitagliptin is a through-process, which challenges the crystallization of the active pharmaceutical ingredient (API) in a batch stream composed of multiple components. Risk-assessment-based design of experiment (DoE) studies of particle size distribution (PSD) and crystallization showed that the final API PSD strongly depends on the seeding-point temperature, which in turn relies on…
View original post 1,634 more words
Filed under: Uncategorized
