ABSTRACT
Many active pharmaceutical ingredients (APIs) can exist in more than one solid-state
form, including crystalline polymorphs, solvates, salts, cocrystals, and noncrystalline or
amorphous solids (Fig. 1; Table 1). Hence, assessment and control of the solid-state
structure of APIs is necessary to ensure efficient and reproducible processing,
manufacturing, and storage; to satisfy regulatory authorities; to protect intellectual
property; and ultimately to deliver safe, effective, and high-quality medicinal products.
This section introduces key practical aspects of solid-state pharmaceuticals, with a
specific emphasis on crystalline solids and their preparation, handling, and analysis,
particularly in the context of preclinical drug development and pharmaceutical
manufacture.
