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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
Bibliography
Bibliography
Websites
ICH (International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use) https://www.ich.org
EMA (European Medicines Agency) https://www.ema.europa.eu
WHO (World Health Organization)
Theses
DURAFOUR (P.-A.) – The importance of stability studies in the pharmaceutical field. University of Lyon 1 (2020).
SCODELLARO (A.) – Review of the stability study process in the pharmaceutical industry: from regulation to implementation to exploitation of observed trends. University of Rouen (2013).
SECRETAN (P.-H.) – Characterization of degradation processes of novel anticoagulants...
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The Ultimate Scientific and Technical Reference