ABSTRACT

Recrystalliza tion 101 6.12. Particle Size Distribution After Thermal Recrystallization 102 6.13. Heterogeneous Nucleation 104 6.14. Crystal Habit 104

References 105

The last step in drug substance manufacture is purification, and this, most often, consists of recrystallization. The conditions under which this is carried out is of great importance in pharmaceutics, because the shape of the particle may affect machinability (e.g., needle-shaped particles may logjam when they flow through a hopper), and the morphology and the shape may affect dissolution. Therefore, a discussion of some of the fundamental factors affecting crystallization is presented.