2. Reactivity study procedures
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 (H 2 O 2 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 Q 1 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...
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Reactivity study procedures
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