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3. Protection methods
The effectiveness of the additives needed to maintain stability by blocking reactions or degradation is linked to their often very marked reactivity and that of the other compounds present. The study of chemical transformations is essential to avoid errors or the use of substances that are not very active, or even unnecessary. Sodium bisulfite protects ascorbic acid from oxidation; however, the degradation of thiamine by sodium bisulfite restricts the use of this antioxidant.
It's not enough to demonstrate oxidation and specify the reaction mechanism. The choice of antioxidant depends on the equilibrium potential between the redox systems of the oxidizable compound and the antioxidant. The optimal concentration of the antioxidant – - not to be confused with the maximum limit tolerated by regulations –- the synergy of action of antioxidant mixtures, their consumption...
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Protection methods
Conclusion
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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