Extractables and Leachables Research is Gaining Maturity

摘要

The pharmaceutical and medtech industries, along with their associated regulators, are paying increasing attention to testing requirements for extractables and leachables (E&L) to guarantee the safety, quality and efficacy of their products. Recent trends in product development and manufacturing have multiplied the risks of unintended chemical changes that could compromise product integrity either during the manufacturing process or on the shelf. Extractables and leachables are organic or inorganic chemical compounds, such as antioxidants, lubricants, polymers, and dyes with potential to migrate into finished products from the containers, container closure, delivery system, packaging (primary, secondary, and tertiary), or various manufacturing components. E&L testing needs to detect, identify, and quantify compounds likely to be present in very low concentrations.