1. Overall assessment of reactivity. Chemical kinetics or reactions
Chemical kinetics play an important role in product stability studies, as well as in biopharmaceutical and drug metabolism studies. Indeed, a thermodynamically favored reaction cannot take place if its rate is infinitely slow, except in the presence of a catalyst likely to accelerate it. The contribution of chemical kinetics will not be developed here; for a more in-depth understanding, readers may refer to articles already published in Techniques de l'Ingénieur.
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The accelerated study of product stability is based on the application of the fundamental theories and principles of physical chemistry and chemical kinetics. In solution, the speed v of a reaction is a function of the number of collisions between the product under study M and the solvent molecules W :
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(1) - PELLERIN (F.), CHANON (N.) -
La réactivité des molécules organiques au service des études de stabilité
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Sci. Techn. Pharm. T 10, 8 (octobre 1981).
(2) - ICH Harmonized tripartite guideline ICH Q1F -
Stability testing of new drug substances and products...
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