The potential adulteration of drug products by extractable and leachable compounds is an area of increasing concern and scrutiny for FDA’s Center for Drug Evaluation and Research (CDER). This contamination is not inherent to the drug itself, but from the container, closure system, disposable component, device, etc., that comes into contact with the drug formulation. The development of unique packaging, novel formulations and delivery systems, and drug-coated medical devices has exacerbated this issue due to the growing possibilities of “foreign” materials coming into contact with drug products. In addition, the increasing applications of single use disposables such as filters, tubing, and bags for biopharmaceuticals can introduce unwanted extractables into the final product.

Extractables are compounds that can be extracted from a component under exaggerated conditions such as in the presence of harsh solvents and/or at elevated temperatures and thus have the potential to contaminate the drug product. Leachables are compounds that leach into the drug product formulation from the component as a result of direct contact with the formulation under normal conditions. Leachables are typically a subset of extractables. Sources of these compounds include plastic components, elastomers, coatings, accelerants, antioxidants, inks, and vulcanizing agents.

The qualification and quality control of all components coming into contact with the drug formulation has become an integral part of any FDA application process. Investigation of potential extractables and leachables must be carried out under International Conference on Harmonization/United States Pharmacopoeia (ICH/USP) guidelines in a current Good Manufacturing Practices (cGMP)-compliant laboratory. These activities may be very time consuming and require a wide array of analytical techniques and expertise. Drug manufacturers may not have the resources available or may want to keep these resources focused on development of new products. Therefore, it is common for drug manufacturers to outsource these activities to contract laboratories.

For information on how Lancaster Labs may assist, please call Business Development at (717) 656-2300.