Understanding The Roles Of Solid-State Characterization And Crystallization Within The Product Lifecycle

The physical properties of a solid active pharmaceutical ingredient (API) dictate the crystallization process used for isolation, purification, and form control and guide the development of an effective formulation. This article describes the role of solid-state characterization and crystallization process development throughout the product lifecycle and explains the importance of developing an early understanding of key solid-state properties for successful downstream processes. It also provides tips for working with partners and building a robust knowledge base in solid form drug development.