A HISTORY OF THE PHYSICAL AND CHEMICAL STABILITY OF PHARMACEUTICALS - A REVIEW

There is a great need for a broad range review of stability tests of active pharmaceutical ingredients (APIs) in comparison with current requirements contained in the pharmacopoeia. This review focuses on a pharmaceutical history of physical and chemical stability determination. Traditional knowledge must be considered in the context of physical stability, while new knowledge must be applied and acquired in terms of identification of each degradation product. Currently, toxicology prediction studies of determined and identified degradation products are the most important aim for both pharmacy and medicine for reasons of patient health and safety. Application of a new analytical approach is currently being proposed for stability testing.