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Analytical method development involves optimizing analytical techniques to achieve the desired performance, including conversion, selectivity, and quality. Different analytical methods may be required for analyzing samples with varying matrices, concentrations, and chemical compositions.
Analytical method development enables the customization of analytical protocols to meet the specific requirements of different applications, industries, pharmaceutical and regulatory standards. Efficient analytical methods with optimized parameters can reduce analysis time and increase sample throughput.
During the route scouting and development phases of a process R&D project, we optimize our analytical method to serve as reliable in-process controls, which enable us to optimize the reaction condition towards high conversion and selectivity, while minimizing impurity formation. These analytical methods form an essential part of our tech transfer package to CDMOs.
Our world-class team of experts also develops methods to ensure that the intermediates and products meet the quality standards required, with a defined impurity profile. We routinely perform analytical method development in our internal and customer projects and have developed expertise in that field using different chromatographic systems (HPLC-DAD, HPLC-ELSD, HPLC-MS, GC-FID, SFC-DAD-MS).
With our SFC and its 14 chiral phases, we can also rapidly address the resolution of enantiomers, both from a preparative perspective and to allow the optimization of enantioselective chemical steps, as part of one of the major challenges in process research.
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