By Justin Hardwick, Research Engineer, Micromeritics
A vital step in determining whether a drug is fit for human use is stability testing, which certifies the drug can maintain its safety and efficacy throughout its proposed shelf life. This includes exposing it to certain storage conditions within its final container. In the current environment of stability testing, the traditional method for determining the presence of foreign particles is simply a visual examination. Yet, in working toward the highest level of safety, quality, and efficacy in drug development, manufacturers must make the move from relying on qualitative, user-dependent results to implementing a fully traceable, analytical, and quantitative method now available in today’s market.