Among those are the drafts of chapters that provide general information, namely USP <1663>, ‘Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems’ and USP <1664>, ‘Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems’.
Draft USP <1663> on ‘Extractables’ is not prescriptive, but provides an information framework on how to design and execute Controlled Extractables Studies. It describes for example the scientific principles and best practices that apply to extractables studies for packaging components. General concepts and design parameters are discussed with respect to the generation of an extract from the packaging system, component or material. Design parameters include the choice of extraction solvents, techniques and conditions. Processes and analytical methods are subsequently outlined for the discovery, identification and quantitation of extractables.
While draft USP <1664> on ‘Leachables’ is equally non-prescriptive, it too constitutes a framework for the design, justification and execution of leachables studies. Leachables in drug products are of concern not only because they may be harmful to patients if delivered in too high doses, but also because they may compromise drug product stability. The use of safety thresholds as a general concept for leachables assessment is thoroughly discussed, as is the use of analytical thresholds in the characterization of leachables. Consideration is given to the analytical techniques used for leachables characterization and to the validation of quantitative analytical methods. Additional considerations are made related to the use of simulation studies as a link between extractables and leachables studies.
Comments on these draft USP chapters were due by November 30, 2013. Datwyler has naturally committed to submitting a number of comments, particularly with respect to USP <1663> on ‘Extractables’. We will of course keep a close eye on this, and keep you, our customer, up to date on all developments.