Impact of Impurities on Crystallization and Product Quality: A Case Study with Paracetamol
09 Jun 2023 | Contributor(s):: Urwin, SJ, Yerdelen, SHouson, I, ter;Horst, JH
A thorough, systematic study into the effect that structurally related impurities have on both the process and product quality during the crystallization of an active pharmaceutical ingredient is presented. The presence of acetanilide and metacetamol influences the crystallization and product...
First-principles and direct design approaches for the control of pharmaceutical crystallization
09 Jun 2023 | Contributor(s):: Fujiwara, Mitsuko, Nagy, Zoltan K. Chew, Jie W., Braatz, Richard D. ;
Crystallization is the main separation and purification process for the manufacturing of drug substances. Not only does crystallization affect the efficiency of downstream operations such as filtering, drying, and formulating, the efficacy of the drug can be dependent on the final crystal form....