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FAQs

What are Polymorphs?

In July 2007, the United States FDA issued technical guidelines for generic drug crystal research, clarifying that polymorph includes crystals, amorphous forms, as well as solvates and hydrates, described as follows:

(1) In the crystalline state, molecules have different arrangements or conformations within the lattice;

(2) In the amorphous state, molecules lack regular arrangement and do not form identifiable lattice;

(3) Solvates contain equivalent or non-equivalent solvents within the crystal lattice. When water is the solvent, it is typically referred to as a hydrate.