Dujuan Lu
E&L Manager/Global Leader
Dr. Dujuan Lu serves as the manager for the extractables and leachables (E&L) team at the SGS Health Science Fairfield New Jersey USA facility as well as the global leader amongst the global E&L centers of excellence. Dr. Lu obtained her PhD in analytical chemistry from the University of Pittsburgh and has extensive CRO and pharmaceutical/medical device industry experience with more than 500 E&L projects. She was named one of the top 60 most influential people working in the pharmaceutical industry in the Medicine Maker’s 2020 power list.
DAY 2: MARCH 8th, 2024
SESSION: A simultaneous UHPLC-UV-CAD-HRMS multi-detector platform for comprehensive extractables and leachables analysis of pharmaceutical packaging and medical device materials
◆ We will demonstrate the combination of the three detection techniques in one system to allow the concurrent measurement of UV absorption, Charged Aerosol Detection (CAD) signal and high resolution-accurate mass (HRAM) mass spectra from one injection.
◆ The inclusion of CAD detection provides complementary information to UV and HRMS, enabling more reliable semi-quantitation of non-chromophoric and non-volatile compounds.
◆ Several case studies will be shown with the application of this multi-detector approach in extractable studies of pharmaceutical packaging and medical device components.
DAY 2: MARCH 10th, 2023
SESSION: Analytical considerations in extractables and leachables testing of drug-device combination products
◆ Regulatory & industry guidance to follow for E&L study design of Drug-Device Combination Products.
◆ Difference & Similarity on E&L requirements between pharmaceutical products and medical devices.
◆ (USP <1663> vs. ISO 10993-18).
◆ Case studies on E&L Testing of combination products.
