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Introduction to Analytical Procedure (Method) Lifecycle Management

12 Mar 2019

The Method Lifecycle Management (MLCM) approach is a holistic approach encompassing all activities, from method development to validation, routine use, change control and retirement of the method. This enhanced approach improves the method understanding and performance, leads to fewer out-of-specifications results (OOS), facilitates method transfer and has the potential to lessen the regulatory burden.

These slides showcase the higlights of a webinar presented by Dr. Horacio Pappa, Director of General Chapters, United States Pharmacopeia, and Dr. Alexander Schmidt, Founder and CEO, and Mijo Stanic, Cofounder, General Manager and Technical Director, Chromicent Pharmaceutical Services, that contains the method lifecycle management key concepts, its benefits to drug manufacturers and patients, and the current thinking of the United States Pharmacopeia (USP), U.S. Food and Drug Administration (FDA) and ICH.

Watch the full webinar on demand here>>

ACQUITY UPC² System

Waters

Convergence Chromatography with the ACQUITY UPC² System Bring streamlined workflow, expanded selectivity, and an orthogonal technique to your laboratory. Convergence chromatography (CC) is a broad-based, complementary analytical platform that is taking its place alongside of LC and GC as one of the three essential separation technologies for modern laboratory analysis. This technique provides another, reliable choice as an analytical platform that is orthogonal to reversed-phase LC (RPLC), while significantly streamlining the entire analytical workflow. In convergence chromatography, the separation is achieved by manipulating the density and composition of a supercritical fluid-based mobile phase. Because of the very high diffusivity of the mobile phase, can be achieved. Additionally, the diversity of stationary phase and mobile phase (co-solvent) options provides access to the largest selectivity space available to any separation technique. The ACQUITY UPC² System is a holistically designed UltraPerformance Convergence Chromatography (UPC²) system that utilizes liquid CO2 as the primary mobile phase. The system leverages the chromatographic principles and selectivity of normal-phase chromatography while providing the ease-of-use of RPLC, enabling you to address routine and complex separations challenges. ACQUITY UPC² System: Discover what's been missing from your analytical toolbox With the ACQUITY UPC² System, scientists can now separate, analyze, and understand compounds that have challenged all other LC and GC technologies including: Hydrophobic and chiral compounds Lipids Thermally-labile samples Polymers It's also the perfect complement to MS due to its low solvent load and high resolution, narrow peaks and fast separations. ACQUITY UPC² System Features: Compressed carbon dioxide (CO2), the primary mobile phase, is less costly and less toxic than liquid mobile phases or carrier gases. Variable volume injection delivers 0.5 µL to 10 µL as well as the ability to match column and injection volume with minimal sample loss and need to change loops. Higher throughput and productivity allows you to analyze more samples per day with faster re-equilibration of columns and shorter cycle times, increasing laboratory productivity. Co-solvent and column switching provides flexibility in method development for faster solvent screening and faster column screening.

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ACQUITY QDa Mass Detector

Waters

The ACQUITY QDa® Mass Detector gives you certainty above all else. You can minimize the risk of unexpected coelutions or components and confirms trace components with the analytical confidence of mass detection. The ACQUITY QDa® Detector is a mass detector built around the needs of analytical scientists for chromatographic analysis. Robust, reliable and requiring no sample adjustments, it just integrates with your current LC, ACQUITY UPLC, ACQUITY UPC2 and purification systems. You'll enhance the analytical value and productivity of each analysis, and you won't need to run all the additional assays or time-consuming alternative techniques or even wait for results from specialist labs that cost your laboratory productivity. With the ACQUITY QDa® Detector, you now have information-rich mass spectral data to complement data from your current Waters® optical detectors, including the ACQUITY UPLC PDA, TUV, ELS, and FLR detectors, as well as the ACQUITY UPC² PDA Detector. This mass spectral information integrates seamlessly into the same workflow; routinely giving you more complete separation characterization. Features: Intuitive operation More information from every sample Effortless integration Increased efficiency Resolving complexity Applications: Food & Environment Life Sciences and Pharmaceuticals Chemical

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Introduction to Analytical Procedure (Method) Lifecycle Management