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6. Glossary
Reactivity; réactivité
The reactivity of an organic molecule corresponds to all the physical, physicochemical or chemical properties common to a part of a molecule or a group of atoms.
Solvolysis; solvolysis
Action of a solvent on a molecule or group of atoms
Hydrolysis; hydrolysis
Action of water on a molecule or group of atoms
Photolysis; photolysis
Photolysis is the action of light on a substance in powder or solution form. ICH recommends irradiating the substance with at least 1.2 million lux · hour with a radiation energy of not less than 200 W · h · m –2 . Handling is carried out in a temperature-controlled chamber.
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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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