Drug stability tests are an essential part of the entire research and development process that must be done prior to a pharmaceutical product that will be made available to the population, in order to determine the time during which it maintains its quality specifications. They consist of a series of tests used to verify physical-chemical, biochemical and immunochemical characteristics, molecular entity analysis, qualitative and quantitative detection of degradation products, as long as purity and molecular characteristics of the drug allow the use of different analytical techniques.
Biological drugs consist of active components that are commonly proteins or polypeptides, in which the conservation of molecular conformation and biological activity depends on covalent and non-covalent forces; which makes them sensitive to environmental factors (temperature, humidity and light), oxidation, ionic content, therefore, well defined storage conditions are needed in order to ensure the conservation of biological activity and avoid its degradation or deterioration.