Waters

Articles by Waters

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.

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.

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.

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.

Applying ISO 10993-18 on Extractables & Leachables Characterization—Supporting the Medical Device Regulatory Pathway

***Live: Friday, November 20, 2020 at 11am EST| 8am PST| 4pm GMT| 5pm CET***Chemical characterization of medical device materials within a risk management process, addressed in ISO 10993 Part 18, was significantly revised in 2020. Part of this critical standard is to ascertain the extractables and leachables from a medical device to enable the estimation and control of biological risks. Join us for this webcast to learn about an LC–MS workflow to help address this challenge.***On demand available after final airing until NOV. 20, 2021***