Regulatory authorities are concerned with the interaction between manufacturing components, drug delivery devices and container closure system and the final pharmaceutical product. Therefore, FDA, EMA and other regulatory authorities require assessment of toxicological risks that could result from these interactions. As an example, the FDA requires that the drug container and closure system should not be reactive, additive or adsorptive as to alter the safety, identity, strength, quality or purity of the drug product beyond the officially established requirements for that product.
For this reason, Extractables and Leachables (E&L) studies form a crucial part of drug product release testing and regulatory submissions. FDA requires E&L testing as part of 510(k) submissions for medical devices.
The ISO 10993-12 and ISO010993-18 provide procedure guidelines for executing leachable study and for the selection of Analytical Methods for characterization. Extractables are inorganic and organic chemical species that can be released under exaggerated conditions of solvent, temperature and time.
Leachables are inorganic and organic compounds that can be released from surfaces of components used in the manufacture and storage of drug products under conditions of normal use.
Xchem will design E&L studies that are responsive to ISO 10993-12 and 10 993-18, that are rooted in sound scientific principles and that follow a risk-based approach. Xchem takes into consideration the intended use and the worst-case scenario models to identify leachables that could potentially migrate into the drug product. Xchem will develop and validate analytical methods for the identification and quantitation of leachables at the toxicity threshold of the leachables.
Contact us to discuss your needs for an E&L study
