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4. Conclusion
Studying the reactivity of molecules is based on in-depth knowledge of the physical, physicochemical and chemical properties of organic compounds. Identifying the compounds formed during deliberate degradation under a variety of conditions, and carrying out reactions between components, is a prerequisite for kinetic studies, predicting shelf life and setting expiration dates. They are a prelude to the prevention of degradation through the choice of appropriate additives, and explain transformations. This is the stage prior to the implementation of stability studies, which are essential for obtaining marketing authorization for drugs or food products, for example. These reactivity studies are indispensable for defining the level of control of raw material purity, with identification and possible quantification of impurities.
Stability studies are thus based on in-depth...
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Conclusion
Appendice
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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