Extractables & Leachables (E&L) Testing

Container closure systems, drug delivery devices, and packaging materials can introduce potentially harmful chemical entities into drug products — making Extractables and Leachables (E&L) testing a critical component of pharmaceutical safety and regulatory compliance. ResolveMass Laboratories offers advanced mass spectrometry-based E&L studies that meet the evolving expectations of FDA, EMA, USP, and ISO standards, including USP <1664> and ISO 10993 frameworks. Our extractables studies employ a broad battery of analytical techniques — including GC-MS, LC-MS/MS, ICP-MS, and headspace analysis — to comprehensively identify and quantify chemical entities that may migrate from materials under controlled extraction conditions. We apply both targeted and ...