Stability studies are used for monitoring and evaluating the quality of Active Pharmaceutical Ingredients (API) and Finished Pharmaceutical Products (FPP) under the influence of different factors such as environmental conditions (temperature, moisture, light), API–excipients interactions, packaging materials, shelf life or container-closure systems during a certain period. Within QP-CMC these are Drug Substance and Drug Product and in certain circumstances extend to testing excipients. This profile conflicts with US Core DiagnosticReport Profile for Laboratory Results Reporting and
US Core DiagnosticReport Profile for Report and Note Exchange on subject, performer, encounter and result. These refer to clinical data collections and re not remotely connected to shelf-life testing of compounds.