2. Reactivity study procedures
One approach to reactivity lies in the study of 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. To this end, climate chambers are used to simulate all the climates standardized in ICH's Q1 procedures in terms of temperature, humidity and light
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Reactivity study procedures
Protection methods
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