One of the key focus areas in API-development for clinical phase II is development of analytical methods. Fermion develops methods of analysis for determining the purity of raw materials, intermediates and final API and tests them for robustness and sensitivity.

Next, the methods are validated and can be included in the IND.

The same methods are also used for monitoring the purity of the product under standard stability test conditions, as well as under accelerated conditions. Special emphasis is used for investigating the conditions under which a compound (raw material, intermediate or final API) degrades (heat, light, oxygen, humidity).