4. Consequences for physico-chemical analysis

4.1 General guidelines

Analytical physicochemistry is not explicitly mentioned as an issue in the regulation, nor as a goal in itself, but as an underlying science involved in many stages of the marketing dossiers for both organic and inorganic substances:

• Characterization of the 14 physico-chemical properties of the active ingredient.

• Characterization of the physico-chemical properties of this active ingredient in the often-formulated commercial product.

Analytical techniques are now well established and perfectly suited to the analysis of active ingredients in high concentrations. The challenge lies in analyzing impurities, catalytic residues and other by-products. Typically, they consist of a separative...