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The Method Detectives: Building a New Business Model with Analytical Procedure (Method) Lifecycle Management

12 Mar 2019

This application note details the benefits of analytical quality-by-design (AQbD) and method lifecycle management (MLCM), being offered by Chromicen. The methods were used alongside a toolbox of Waters LC systems, chemistries, and software to solve customers' challenges with method development and validation. AQbD takes a holistic approach in order to allow an overall understanding of method performance. These are based on numerous multidimensional combinations and interactions of the factors involved in a product's lifecycle – from the idea, development transfer, marketing, and sale, to its discontinuation. The adoption of Waters ACQUITY UPLC and ACQUITY QDa technology has provided Chromicen with faster information, earlier in the method development process, contributing to their business success.

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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ACQUITY UPLC System

Waters

Waters ACQUITY UPLC - Dramatic Improvements in Speed, Sensitivity and Resolution Whether you work in methods development or quality assurance, in drug discovery and development or testing for safety in food supplies, you seek a productivity edge. With the ACQUITY UPLC® System, now you can get more information in a single, short run than you've ever seen with HPLC. Waters ACQUITY UPLC System UltraPerformance LC® (UPLC®) technology starts with unique 1.7 μm small-particle chemistries. Chromatographers no longer need to choose between speed and resolution–with UPLC you get both. Instrument Designed for Chemistry; Chemistry Designed for the Instrument The ACQUITY UPLC System has been holistically designed to match the performance needs of our innovative column chemistries with robust hardware, easy-to-use software and specialized support services. Small, pressure-tolerant particles High-pressure fluidic modules Minimized system volume Negligible carryover Reduced cycle times Fast response detectors Integrated system software and diagnostics With UPLC you have the ability to work more efficiently with higher speed, sensitivity and resolution at a much wider range of linear velocities, flow rates and backpressures to obtain superior results. The Waters ACQUITY UPLC System's high-pressure fluidics optimizes flow rates to make the most of small particle technology. The ACQUITY UPLC System's sample-handling design is designed to ensure exceptionally low carryover and reduced cycle time. And when interfaced with the Sample Organizer, it increases unattended sample capacity by ten times. High-speed detectors, both optical and mass, contribute to increased sensitivity and help manage the heightened speed and resolution requirements of UPLC. ACQUITY UPLC Systems are easily controlled, diagnosed, and monitored via a graphical system console interface. The console offers: Quick and easy access to critical instrument parameters Simple system start-up, elegant system status monitoring and predictive performance indicators to ensure maximum productivity Data management capabilities that are supported by both MassLynx™ and Empower™ software The ACQUITY UPLC System is also supported by Intelligent Device Management technology with our Connections® INSIGHT™ service, providing instrument diagnostics.

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