Webinar

Managing the complexities of NDSRI method development: The N-nitroso propranolol case story

11 July 2024

1:00pm

In this webinar, Dr Marian Twohig, Principal Scientist at Waters Corporation, will provide an overview of the more recent progress around N-nitrosamine regulations.

With the latest regulatory updates encompassing a pragmatic and structural related approach to determining the risk of N-nitrosamine impurities in pharmaceuticals, there remains the ongoing need for pharmaceutical manufacturers to consistently mitigate and control levels of these impurities in new and existing products. When required, analytical testing plays an important role in ensuring levels remain below regulatory acceptance thresholds.

Driven by the latest regulatory guidelines, Dr Twohig will share a comprehensive overview of the development of an analytical methodology for the quantification of N-nitroso propranolol in propranolol, citing unexpected challenges and the resolutions that lead to robust method optimisation beyond regulatory required thresholds.

Key learning objectives:

  • Align analytical method optimisation to current regulatory guidance
  • The importance of high-quality chromatographic methods to facilitate ease of API and isomeric impurity resolution
  • Accessible approaches in tandem quadrupole mass spectrometry solutions supporting the investigation and tentative identification of unexpected peaks and other method optimisation challenges.

Interested? Fill in your details to secure your spot!

OUR SPEAKER

Dr. Marian Twohig – Principal Scientist Waters Corporation

Dr.Marian Twohig is a scientist with a passion for problem solving using analytical instrumentation. She has over 18 years of experience supporting quantitative and qualitative applications in the pharmaceutical, food and environmental and materials science industries. She works as a Principal Scientist for Waters Corporation where she has previously held several Senior Scientist positions.

FAQs

FAQs 

Is the webinar free? 

Yes – there is no charge to watch the webinar, either live or on-demand. 

When will the webinar take place? 

11 July 2024 at 3.00pm GMT. 

Can I watch it later? 

The webinar will become available to watch on-demand shortly after the live webinar takes place. 

What are the benefits of attending live? 

You’ll be able to ask the speakers your questions, which will be answered live in the Q&A towards the end of the session. 

How long will the webinar be? 

This webinar will last up to an hour. 

What do I need to watch this webinar? 

All you need is a computer with an internet connection. We recommend using headphones if possible if you’re in an office environment.