Reactivity study procedures
Réactivité des molécules organiques et stabilité

One approach to reactivity is to study the impact on the substance of various conditions, dry or in solution: the action of temperature, light, acidic (HCl 0.1 N to 1 N) or alkaline (NaOH 0.1 N to 1 N), oxidizing (H₂O₂ 0.1 to 10%) or reducing reagents. These parameters must be kept constant and reproducible over the test period. Climatic chambers are used to simulate all the climates standardized in ICH Q₁ procedures in terms of temperature, humidity and light. .

But it is also necessary to carry out accelerated degradation more drastic than the ICH protocols, using excessive storage conditions to highlight the molecule's weak points, accompanied by identification and structural determination of the compounds formed. It is even possible to heat the substance to 70°C for several days to obtain at least 20% degradation products, while avoiding excessive decomposition....