Streamlined Development of Analytical Methods for Trace Level Genotoxic Impurities: Simplifying Workflows, Optimizing Performance and Mitigating Analytical Risk

Solving Problems That Matter: Nitrosamine Analysis

Expert Insight 3-Part Webinar Series: Upskilling Your Analytical Strategies for Nitrosamine Detection and Control to Proactively Address Safety in Pharmaceutical Product Development.

Unacceptable levels of N-nitrosamine impurities, which may increase the risk of cancer, have been found in some medications resulting in drug recalls, warning letters, and therapeutic shortages. To ensure that the residual level of nitrosamines in your drug products related to your drug development and manufacturing processes is within safe amounts, highly sensitive and specific analytical methods need to be used for the detection, characterization, and quantification of such impurities. Learn how your colleagues have upskilled their lab capabilities and technologies to elucidate the nature of unknown materials in complex drug substances, using a variety of analytical techniques.

In this timely virtual webinar series, pharmaceutical scientific experts discuss key analytical strategies on how to improve methods for nitrosamine impurity detection and characterization, and how sharing this expertise can help your pharmaceutical scientists support your product quality, safety, and efficacy

PART 3 | Streamlined Development of Analytical Methods for Trace Level Genotoxic Impurities: Simplifying Workflows, Optimizing Performance and Mitigating Analytical Risk

When a need for analytical testing follows a N-nitrosamines risk assessment, a new sensitive quantitative analysis method, specific to the pharmaceutical product, must be developed. The method development process can, however, be time consuming and challenging for even the very experienced analytical laboratory. The challenge of method development is exacerbated by prevalent Complex N-Nitrosamines Drug Substance Related Impurities (NDSRI) in pharmaceutical medicines where, in cases, the extremes of low acceptable thresholds must currently be controlled through testing using bespoke, very highly sensitive, and analytically robust methods.

This webinar focuses on the efficient development of optimised quantitative methods for the analysis of genotoxic impurities (GTIs), e.g. N-nitrosamines. As there is no ‘one size suits all’ in N-nitrosamine analytical methods, efficient development of quantitative methods can be facilitated through the implementation of streamlined workflows, where using performance technologies, quality products and consumables together will support a simplified end to end analytical workflow. In this webinar we will discuss systematic approach to quantitative method development with flexibility to meet todays and future testing needs. We will share how Waters latest analytical and sample preparations technologies align with quality, selective chemistries for simplified workflows in the development of optimised quantitative assays for GTIs and how these assays are further strengthened by the inherent mitigation of analytical errors.

Presenter: Amy Bartlett (Global Pharmaceutical Market Development, Waters Corporation)

Amy’s role in Pharmaceutical Market Development, within Waters’ Global Testing and Lab Services business, centers primarily on analytical solutions and workflows to support the Pharmaceutical Industry’s quantitative analysis needs. Specifically, Amy is focused on Waters Tandem Mass Spectrometry-centric solutions that tackle the industry's most pressing issues, including the challenging regulated analysis of trace level genotoxic impurities.

With nearly 17 years’ experience at Waters, Amy has established expertise in quantitative LC-MS/MS analysis and throughout this time led teams of experienced applications scientists providing application and scientific support to Waters' customers across a broad range of markets, applications, and technologies. Prior to joining Waters, Amy worked for several years in the pharmaceutical industry in Analytical Development and Discovery DMPK roles. She obtained a BSc in Chemistry from the University of Warwick, UK, before embarking on her career in the industry.