Recent breakthroughs in the stability testing of pharmaceutical compounds

Marzena Jamrógiewicz; Krystyna Pieńkowska

doi:https://doi.org/10.1016/j.trac.2018.12.007

Recent breakthroughs in the stability testing of pharmaceutical compounds

Abstrakt

Pharmaceutical development is mostly focused on the research leading to approval of a new and viable active substance. However, there is a number of old generation compounds that are still being used in contemporary medicinal practice. So that new analytical developments should cover not only the safety of newly developed drug substances, which is obvious, but should also be directed into the search of individual stability issues for both new and old-generation compounds. Pharmacopoeias recommendations do not keep up with the progress within scientific publications regarding impurities already
recognized and published. This article summarizes existing knowledge on the latest pharmaceutical stability requirements, on the basis of one of the most well-known drug substance implemented into pharmaceutical market almost 40 years ago. We present a new insight into the stability studies regarding recent breakthroughs in the stability testing of pharmaceutical compounds.