Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Transport, Storage and Analysis

Residual solvents are organic volatile chemicals used or produced in the manufacture of active pharmaceutical ingredients (API), excipients or drug products, which remain in the material at the end of the manufacturing process. Their control is important in limiting exposure and guidelines exist to maintain patient safety, not just to satisfy competent authorities. It is a requirement that all pharmaceutical substances comply with ICH limits even if not required by individual monographs or if no compendial monograph exists. This application note proposed enhancements that can be applied to the sample preparation schemes outlined the USP <467> Residual Solvents general chapter. However, they can also be applied to all pharmacopeias complying with the ICH guidelines for residual solvents.