Organic solvents are commonly used in the production of active pharmaceutical ingredients (API) and pharmaceutical products. The solvents are used for varying purposes including as synthesis reaction media, in the separation and purification of API during synthesis, to enhance yield, to impart desired characteristics such as crystal form and solubility, and other uses. The manufacturing process does not always consume or breakdown all of the solvent, thus it is not uncommon for residual amounts of solvent to remain in the final product. Residual solvent levels must meet health-based limits to ensure patient safety. The United States Pharmacopeia (USP) Chapter 467 identifies residual solvents of potential concern for pharmaceuticals, defines acceptable concentration limits, and provides detailed techniques for screening, confirmation, and quantitation of residual solvents, including sample preparation and analytical conditions.
This application note reports the results from the analysis of residual solvents according to USP 467 requirements performed with the 爱游戏平台注册登录 GC 2400™ System and the 爱游戏平台注册登录 HS 2400™ Headspace Sampler, showing improved productivity and lab time optimization.