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.
Nitrosamine Exchange – a USP’s knowledge community for all-things Nitrosamine
The Nitrosamine impurities crisis prompted regulators around the world to increase their scrutiny of drug manufacturing processes even further. In the future, this greater scrutiny may lead to the discovery of nitrosamine impurities in other medicines. For this reason, manufacturers need to understand which medicines are likely to form nitrosamines, how and at what levels nitrosamine impurities are forming, and how to control nitrosamines. In the following seminar we will explore how USP responded to the nitrosamine impurities crisis not only with a proposed general chapter on nitrosamine impurities but also non-compendial resources and tools that provides a risk assessment strategy, methods for detecting and measuring nitrosamine impurities. In that effort, USP built a knowledge community dedicated to All-things Nitrosamines.
Register Here: Nitrosamine Exchange – a USP’s knowledge community for all-things Nitrosamine
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Set a reminder in the community by clicking YES I will attend, or add to your calendar !
**By using the RSVP to set a reminder you can join the conversation around the event, or receive updates in the community.
Naiffer Romero has more than 18+ years of pharmaceutical industry experience. In his 10 years tenure with USP, he has served several roles: Lead scientist in performance testing compendial reference standards development, Manager in charge of LATAM Compendial engagement and education with stakeholders and national regulatory bodies. Romero is also a certified USP Education instructor. Most recently, he joined USP’s Scientific Affairs performance cell where he leads scientific outreach and engagement for LATAM & US region on key national health priority topics. His combined pharmaceutical expertise includes analytical development, salt and polymorph selection, development of dissolution methods, IVIVC modeling, and impurity analytical strategy. Romero also served as member of USP’s Nitrosamine Steering Committee and community host to ‘Nitrosamine Exchange’, a knowledge community in all-things nitrosamine. Naiffer also liaises technical discussions on pharmacopeial collaboration including International meeting of World Pharmacopeias (part of WHO).
United States
