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FAQs

What are Polymorphs?

In July 2007, the United States FDA issued the technical guidelines for generic drug crystal research, pointing out that polycrystalline polymorph includes crystal or amorphous, as well as solvates and hydrates, which are described as follows:

(1) In the crystal state, the molecules have different arrangements or conformations in the lattice;

(2) In the amorphous state, the arrangement of molecules is not regular, and there is no identifiable lattice;

(3) Solvent is the crystal lattice containing equivalent or non-equivalent solvent. If the solvent is water, the solvent is usually called hydrate