Santandrea, Ernesto, Waldraff, Christine, Gerber, Gilles, Moreau, Mael and Beney, Pascal (2021) Development of the late-phase manufacturing process to ZPL389: control of process impurities by enhanced process knowledge. Organic process research & development.

Abstract

The development of the late-phase manufacturing process to the drug candidate ZPL389 is described. The strategies for the control of impurities are outlined in detail. The development of the late-phase synthesis route allowed a thorough control of the process impurities leading to an improvement of the quality of the drug substance, as well as to an increase of the overall yield of the manufacturing process and a reduction of the PMI.

Item Type:	Article
Keywords:	ZPL389, 2-aminopyrimidines, salt formation, nucleophilic aromatic substitution, metal-free aromatic amination, impurity control
Date Deposited:	29 Apr 2021 00:45
Last Modified:	29 Apr 2021 00:45
URI:	https://oak.novartis.com/id/eprint/44325