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Articles

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.

Improvements in Chromatographic Performance for Stability Indicating Methods of Antiviral Drugs with MaxPeak Premier Technology

Chromatographic methods developed to analyze pharmaceutical compounds must distinguish low-level impurities before they reach alert/action levels. Parameters such as retention, peak shape, and sensitivity are very important to successfully accomplish this. Read this app note to learn more about MaxPeak Premier Technology.

Continued Performance Verification of Analytical Procedures Using Control Charts of Empower Chromatography Data Software

This white paper describes the use of Empower™ 3 Control Charts to facilitate the continued procedure performance verification stage of the analytical procedure lifecycle approach.

Modern Perspectives on Method Development: An Interview with Dr. Fadi Alkhateeb

Modern approaches to analytical procedure development such as Analytical Quality-by-Design (AQbD) focus on the reliability and accuracy of the final result, encouraging Analytical Developers to understand how aspects of sampling, storage, sample preparation, personnel training, instrument parameters, and data handling might affect result reliability. Find out more about AQbD and the best tools to design and develop fit-for-purpose methods.