3.2.S.3.1 - Elucidation of Structure and Other Characteristics

Chemical structure:

Elucidation of the chemical structure should be provided, based on the synthetic route and appropriate instrumental methods.

• For APIs for which a pharmacopoeial reference standard is available, comparative identification tests may be provided.

Solid phase properties:

A discussion and characterization of solid phase properties of the API should be provided, as applicable.