Module 3 2019

S.3.1 Elucidation of Structure and other Characteristics ➢ Full elucidation or with reference to a pharmacopoeial standard ➢ Evidence of Chemical Structure ➢ Physicochemical properties

Synthetic route Key intermediates

Solubility

− − − − −

− − − − −

Physical characteristics

Spectroscopic evidence

Polymorphism

Crystallography Elemental analysis

Partition coefficient

Hygroscopicity

➢ Potential Isomerism

Asymmetric carbons

− −

Other isomers

Nomenclature and Characterisationof the Active Ingredient

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