AQbD Method Development: Reduce Out-of-Specification Results and Gain Regulatory Confidence

See how implementing an enhanced approach, like Analytical Quality by Design (AQbD), for method development can help you to access high quality, reportable data.

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

This case study determines the adoption of Waters ACQUITY UPLC and ACQUITY QDa™ technology in contributing to the success of independent pharmaceutical service provider Chromicent, by providing more information faster and earlier in the method development process.

Analytical Quality by Design Based Method Development for the Analysis of Valsartan and Nitrosamines Impurities Using UPLC-MS

In this work, an UltraPerformance Liquid Chromatography method was developed for the analysis of Valsartan and a mixture of six genotoxic impurities using the Analytical Quality by Design (AQbD) approach. Findings indicated that using the AQbD approach and automated software helps gain a deep knowledge about the method and as a result, increases method robustness and reproducibility.

Analytical Procedure MLCM Drives Method Development at Innovative CDMO

Learn how Hovione, a global CDMO, has determined that the combination of Waters instrumentation and AQbD is a powerful strategy for method development that leads to better, faster, greener analytical methods, enables resource optimization, and more.

Analytical Quality by Design Based Method Development for the Analysis of Dexamethasone Phosphate and Related Compounds Using Arc Premier MaxPeak High Performance Surfaces (HPS) Technology

Using the Analytical Quality by Design (AQbD) approach, an Ultra High Performance Liquid Chromatography method was developed for the analysis of a mixture of metal chelating and non-chelating compounds. DryLab, Empower, and Waters systems were used to automate the method development process.

Applying a Software-Assisted Analytical Quality-by-Design Approach for the Analysis of Formoterol, Budesonide, and Related Compounds by UPLC-MS

Analytical method performance is critical to ensure the quality, safety, and efficacy of pharmaceutical products. Two of the most commonly used ones are One Factor at a Time (OFAT) and Analytical Quality by Design (AQbD). In this work, a robust method for budesonide, formoterol, and related compounds was developed using a Quality by Design approach on an ACQUITY UPLC H-Class PLUS System running Empower 3 and Fusion Software.