Marzena Jamrógiewicz, Karolina Milewska, Klaudia Lewandowska, Karolina Czubak

Definitions and analytical procedures concerning pharmaceutical compound stability and the shelf-life of the drug product 
2018-02-15

DOI: 10.32383/farmpol/119462

Chemical and physical stability of medicinal substances and the finished medicinal product is a key aspect of ensuring high-quality medicine and safety of therapy. Currently, every analytical approach including minimization of the risk of degradation of the medicinal substance and elimination of products with potential genotoxic risk is a priority in the registration and implementation such proceedings. Huge interest in the subject of stability resulting from the need to ensure high-quality medicine has been going on for many decades, and recently has increased significantly not only in the scientific literature, but also in procedures and guidelines. Leading institutions related to health surveillance and pharmacotherapy, such as the FDA, WHO and ICH, are constantly introducing new recommendations to minimize the risk of side effects and undesirable pharmaceutical products for human use. Thanks to technological progress, it is possible to control the quality of medicinal products much more than several dozen years ago. The work concerns the review of the latest analytical trends, as well as discussing existing problems with the current stability test guidelines.

Keywords: stability, shelf-life, pharmaceutical quality control, solid state, guidelines

© Farm Pol, 2018, 74(2): 95-108