IIn recent years, the pharmaceutical industry has developed a better understanding of the impact of extractables and leachables on patient safety and drug product interaction, leading to increased scrutiny from regulators. A study should be conducted to determine the profile of extractables in the container closure components that are in contact with the formulation during storage and/or use. For compounds that appear as leachables present in the formulation at the end of the shelf life of the product or sooner, identification should be attempted and safety assessments should be conducted in accordance with adequately established safety thresholds.
We have developed the following methodology to analyze extraction solutions by LC/MS, GC/MS, LC/UV: