Extractables and Leachables Studies: Designed and Performed to Meet All Intended Needs

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There are no definitive requirements on how to perform extractables and leachables (E&L) studies. However, the US Pharmacopeial Convention recently released two chapters to provide guidance on performing E&L studies. USP chapters <1663> and <1664> discuss options and considerations in performing an extractables study and a leachables study, respectively. There are also various workgroups that have published guidance documents to assist industry in designing and performing these studies. The Product Quality Research Institute (PQRI), the Bio-Process Systems Alliance (BPSA), and the Bio-Phorum Operations Group (BPOG) all have released publications defining best-practices approaches to perform the testing. The PQRI guidance document focuses primarily on performing studies on orally inhaled and nasal drug products. Both BPSA and BPOG focus on the evaluation of single-use technology. Although the general approaches to generating an extractables profile of a contact material are similar, the details in performing the studies differ. In addition, ASTM has formed a working group establishing a standard for single-use technology. Eurofins Lancaster Laboratories staff members are participating on this working group and have experience in performing studies following any of these workgroup guidances as well as establishing custom study designs to meet all intended needs.

Typically, an extractables study involves incubation of components in solvents of varying polarity under elevated temperatures. The extraction may involve incubating components at elevated temperatures or using sonication, accelerated solvent extraction (ACE), a Soxhlet extractor, or reflux to extract the component. The resulting extracts are then tested by different analytical techniques to generate a broad extractables profile that then can be used to perform a safety assessment. Typically, such analytical techniques use mass spectrometry to allow for identification of the observed extractable compounds.

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