Extractables & Leachables: Understanding Container & Device Interactions

When developing a drug product, it is vital to ensure the product that reaches patients has not been contaminated or adulterated in any way by its packaging. Although the risk is low for solids, such as tablets and capsules, with liquid injectable and inhalable drugs, there is a real possibility that chemicals from the packaging might leach into the drug itself. Regulatory bodies, such as FDA, have strict rules regulating adulterants; therefore, conducting studies to identify and quantify any such contaminants is an important step in the drug-development process…