For the pharmaceutical industries the manufacturing standards reach to meet the highest level in industry. The regulations of the US Food and Drug Administration (FDA) require that every phase of the manufacturing process is cautiously controlled to ensure the quality of product stability. Formulation testing is one of these routine procedures performed on drug substances and products and is involved at various stages of product development and production. For consistent monitoring, a large number of sample measurements are performed at intervals for various parameters, which may include active ingredients, known degradation products, dissolution time, appearance, etc. Various analysis techniques are used to achieve this goal, including High Performance Liquid Chromatography (HPLC) and other types of chromatographic methods. While these techniques are established as an analytical standard, they are in many cases undesirably slow or insufficient in information content. Therefore, a detailed understanding of the mechanisms in formulation instabilities requires often a number of complementary techniques.

AquaSpec™ Technology by micro-biolytics, e.g. like EQUILA-CHECK, is a new analytical method to check pharmaceutical formulations with the aim to combine both, the desirable sample throughput and the necessary grade of information to understand what is going on in a formulation.