Author Archives: Thomas Lehman

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…

August 10, 2017

Lancaster Labs Develops Extractables Database for LC/MS Analysis

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The FDA has been focusing effort into evaluation of potential adulteration of drug products due to contact with packaging and closure systems, sample delivery devices, and components used in product manufacturing. Packaging includes components such as vials, caps, and stoppers. Drug delivery devices include nebulizers and inhalers. Components used during product manufacturing include filters, tubing, fittings, connectors, bioprocess bags, and bioreactors. Lancaster laboratories provides support by performing extractables and leachables testing. Extractables are compounds that can be extracted from a…

July 1, 2010