As part of the regulatory drive to ensure the safety and effectiveness of drug products, manufacturers of pharmaceuticals, drug delivery systems, and biomedical devices have come under growing pressure to monitor and control contaminants.
This includes the requirement to perform sensitive and accurate analysis to detect, identify, and quantify extractable and leachable compounds (E&Ls), as per various regulations. E&Ls may be inherently toxic, or contaminate or interact with drug products, posing a potential danger to patient health.
E&Ls fall into several different chemical classes, a broad range of molecular weights and physico-chemical properties; hence, no single analytical technique is best suited to their analysis. As a result, testing for E&Ls focuses on the complementary use of many analytical technologies.