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 (H 2 O 2 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 Q 1 procedures in terms of temperature, humidity and light
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Reactivity study procedures
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