Extractables & Leachables Analysis
Extractables & Leachables analysis includes the detection, identification, toxicological evaluation, and monitoring of potentially harmful chemicals that can leach from drug products or medical devices into the patient. The source of these chemicals can be materials used in the construction of primary and secondary packaging, manufacturing equipment, or medical devices. Regulatory agencies such as the FDA and Health Canada require that leachables be evaluated in the drug product or medical device during stability to ensure patient safety. Boston Analytical's staff has experience evaluating Extractables & Leachables in pharmaceutical packaging, medical devices, drug-delivery/combination products, processing equipment, Single Use Systems, e-cigarettes, and consumer product packaging.
Extractables testing is conducted on the material(s) of interest using neat solvents to extract all potential leachables from each material employed in the package system. The extracts are analyzed to produce a profile of potential leachables. These can include polymer additives such as antioxidants and plasticizers, dyes, catalysts, or residual manufacturing solvents. The extraction conditions are developed specifically for each drug product and packaging system.
Leachables testing is done on the drug product or medical device directly. The product is tested directly for the presence of any unwanted chemicals (leachables) that have leached into the product. Methods are developed and validated specifically for the drug product or medical device, which target the potential leachables identified in the Extractables study. The validated methods are employed to test the product on stability, to simulate the product at the shelf life.