Webinar Highlights Strategies for Identifying Unknown Extractables and Leachables

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Webinar Highlights Strategies for Identifying Unknown Extractables and Leachables

Team TFS
Team TFS

E&L Cropped.jpg



AnalyteGuru continues its Networking in Science webinar series with Paulina Pinedo-Gonzalez, Ph.D., from SGS, Fairfield, New Jersey, on May 11 at 10 a.m. CDT. In this webinar, Dr. Pinedo-Gonzalez will present the strategies SGS employs to identify unknown extractables and leachables (E&L) in pharmaceuticals.


Click here to register now


Extractables and leachables overview


Accurate identification of extractable and leachable (E&L) compounds is vital to ensure 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.


Looking for additional information about E&L analysis? Check out our blog post, Thermo Fisher to Present End-to-End E&L Solutions at Extractables & Leachables USA.


Additionally, if you are looking for resources on E&L impurities, explore our E&L Information webpage.


Why is it important to test for E&L compounds?


Accurate identification of E&L compounds is vital to ensure that products we consume or use are safe. It also safeguards that there are no potentially harmful chemicals being absorbed into a finished drug product, medical device, or food contact material when it is manufactured, packaged or stored.


What approach does SGS take to analyze E&Ls


High-resolution mass spectrometers (HRMS) that enable an accurate mass determination, such as the Thermo Scientific™ Orbitrap™ LC-MS, 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.


Dr. Pinedo-Gonzalez will share strategies that demonstrate practical steps to follow for structural elucidation of unknown non-volatile and semi-volatile organic compounds based on their LC-MS spectra. This stepwise 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.


What are the key learning objectives of this webinar?


  • Practical tips to identify semi-volatile and non-volatile E&Ls from pharmaceutical and medical products by LC-MS
  • The importance of high-resolution mass spectrometry in the inference of a molecular formula for an unknown ion
  • Advantages of incorporating MS/MS information for the structure elucidation of unknown compounds


Don’t miss out on this webinar. Click here to register now.


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Meet the presenter


Paulina-headshoot Lower res 2.jpgPaulina Pinedo-Gonzalez, Ph.D.
E&L Chemist II
SGS Health Science



Dr. Pinedo-Gonzalez is an E&L chemist at SGS Health Science in Fairfield, NJ. At SGS she focuses on 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.


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