Abstract
The quality of active pharmaceutical ingredients and finished pharmaceutical products is of utmost importance. Since stability is one of the pillars of quality it must carefully be studied before approval. Stability studies follow a strong regulatory framework, such as those established by the International Council for Harmonisation and take a lot of time. First, stress testing under harsh conditions over several days and accelerated studies over 6 months are performed to generate a likely degradation profile. With this collection of degradants, a stability-indicating chromatographic method, mostly high-performance liquid chromatography, can be developed which is able to quantify the active pharmaceutical ingredients and all degradation products. Afterwards, a long-term study must be carried out to determine the storage conditions and expiry date of a medicinal product. As stability studies do not last longer than five years, the maximum shelf life stated on the packaging is five years at the most. Whilst the current regulatory framework has successfully established high standards for the quality and safety of medicinal products, there is still considerable scope for improvement. This review aims to bridge the gap between established guidelines and new technological advances, and introduces mechanochemistry as a novel, rapid and cost-effective screening alternative to conventional stress tests. Furthermore, this article takes a critical look at the clinical reality of strict expiry dates for medicines. Drawing on real-world data and independent studies, it shows how rigid expiry dates lead to significant wastage of medicines worldwide, placing a financial burden on healthcare systems and causing avoidable ethical conflicts. Overall, this review demonstrates how updating current testing paradigms can safely minimise the waste of resources without ever compromising patient safety or clinical efficacy.