Strategies for the identification of unknown extractable and leachables by LC-HRMS

Strategies for the identification of unknown extractable and leachables by LC-HRMS

Accurate identification of extractable and leachable (E&L) compounds is vital to ensure that there are no potentially harmful chemicals being absorbed into a finished drug product or medical device when it is manufactured, packaged, or stored. Identifying trace levels of unknown E&L compounds in matrices, sometimes relatively complex, is a challenging task. High resolution mass spectrometers (HRMS) that enable an accurate mass determination such as LC/MS-Orbitrap generate high quality data that can often lead to the identification of an empirical formula and narrows down the class of compound of the unknown. Based on this information, the identity of an unknown is further evaluated following a systematic approach. Through a case study approach, we will demonstrate the practical steps followed for structural elucidation of unknown non-volatile and semi-volatile organic compounds based on their LC-MS spectra. This stepwise and collaborative approach in structure identification has proven useful for the effective identification and quantification of E&L compounds in a variety of pharmaceutical and medical products.

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Paulina is an extractable and leachable chemist at SGS Health Sciences in Fairfield, NJ. At SGS she focuses on extractable and leachable (E&L) testing of pharmaceutical containers and medical devices by GC-MS/FID and LC-MS/PDA. Prior to joining SGS, she was a postdoctoral research associate at Columbia University, working on high resolution mass spectrometry applications mainly for the environmental field.