Small Molecule Method Development

Throughout the drug development process, methods are developed at various stages, often consisting of samples that vary in complexity. Due to the inherent nature of this process, costly and time-consuming redundant efforts may take place across an organization.

Our system for pharmaceutical methods development integrates Waters' class-leading components:

• ACQUITY UPLC H-Class PLUS System – Featuring quaternary solvent management and the ability to run either HPLC or UPLC columns
• AutoBlend Plus – Automating the formulation of gradients
• ACQUITY QDa Mass Detector – Providing easy-to-use orthogonal detection to UV
• Fusion Method Development Software – To design your experimental space
• Empower Chromatography Data Software (CDS) – For complete system control from data analysis to compliance management
• Empower Method Validation Manager Software – Automates validation steps, from protocol planning through final reporting.
• Waters UPLC Method Development Chemistry Kits – to meet your selectivity requirements

The ACQUITY UPLC H-Class PLUS System for Methods Development combines UPLC chromatography with smart software tools that are designed to help you automate the complex steps in developing and validating a method, and to move projects forward in a fraction of the time compared to HPLC.

And by using the ACQUITY QDa Mass Detector to complement UV data with mass data, you'll have orthogonal visibility to potential coelutions and the ability to confirm trace components.

Whether you're ready to adopt QbD processes, or need a chromatography system the provides versatility and reliability you need to achieve consistent and repeatable methods, ACQUITY UPLC H-Class PLUS System is ready for your laboratory.

Many different approaches are applied to develop chromatographic methods today, including trial and error, method and column scouting, and software-based approaches such as first-principles approach and simplex optimization procedures. These approaches cannot, however, determine the effects of complex interactions between method variables or measure method robustness. Approaching method development from a Quality by Design (QbD) can address these challenges.

The ACQUITY UPLC H-Class PLUS System is ideal for use with QbD-based methodology for LC method development, allowing you to develop the best possible method much faster and with greater confidence. Fusion Method Development Software integrates with Empower 3 and ACQUITY UPLC to design statistically-valid experiments and automatically builds fully ready-to-run sequences.

Fusion Software then uses the resulting data to generate parameter-effects models which establish the final design and operating spaces for truly optimized LC methods. Utilizing a patented approach built on sound statistical process control techniques, Fusion Software computes and models the impact of key chromatographic parameters on method robustness. This enables identification of methods optimized for both mean performance and robustness without the need for any additional experiments.

The system configuration takes full advantage of the quaternary ACQUITY UPLC H-Class PLUS System's multi-solvent blending, versatile column management options, and reliable Method Development Kits available in a variety of chemistries.

With the ACQUITY UPLC H-Class PLUS Method Development System, your ability to ensure a quality method is developed the first time is unmatched.