Margaret is responsible for development, validation, and transfer of analytical methods within the pharmaceutical applications development team, based in Milford, MA. She specializes in development of new applications on Waters instrumentation and related control software, creating technical seminar materials, marketing collateral and demo projects to support the sales and marketing organizations globally. Margaret also supports testing and development activities of instruments and software solutions. Before joining waters, Margaret worked at Boston Scientific and Purdue Pharma.
The analytical methodology applied for genotoxic impurity analysis needs to provide an appropriate level of sensitivity to meet the required detection limits and demonstrate good accuracy, precision, and reproducibility. In this work, we present robust analytical approaches for the detection and quantification of nitrosamine impurities using UV, MS and HRMS techniques. The performance and sensitivity of these methodologies are demonstrated by analyzing several nitrosamine impurities in drug substances and drug product formulations.View Details