Virtual seminar session 1: Impurity analysis with a focus on nitrosamines

Nitrosamine (genotoxic) impurities have been found in some angiotensin II receptor blocker (ARB) medicines, such as valsartan, and more recently in histamine-2 receptor blocker medicines, such as ranitidine, drawing close scrutiny from FDA, the European Medicines Agency (EMA) and other regulatory bodies leading to product recalls.

Gas chromatography–mass spectrometry (GC-MS) has typically been the detection technique of choice; however, not all nitrosamines can be analyzed this way. As the number of known nitrosamines requiring trace level quantitation increases, the greater the need for robust, sensitive, and high-throughput assays to provide a cost-sensitive approach of a single analysis capable of accurately measuring all compounds. The use of liquid chromatography with high-resolution MS (LC-HRMS) allows low level detection and high confidence of a wider range of nitrosamine impurities.

Session breakdown:

11:00 CEST, 10 minutes + Q & A

Introduction to impurity analysis challenges and regulatory requirements in Europe

Presenter: Jon Bardsley,Pharmaceutical Marketing Manager , Thermo Fisher Scientific

11:20 CEST, 20 minutes + Q & A

Chromatography and Mass Spectrometry software for GMP impurity testing

Presenter: Darren Barrington-Light, Software Product Marketing Manager, Thermo Fisher Scientific

This session will give an overview of the current landscape of impurity testing in general and with a focus on nitrosamines and the European regulations. We will then cover our software, Chromeleon for Mass Spectrometry with an overview and focus on data integrity and compliance. You will have a chance to ask questions to our specialists on these topics.

Key Learning Objectives:

• Why is the analysis of genotoxic impurities important?
• Method development considerations for trace level impurities
• What are the current regulations in Europe?
• The role of compliance in data software with mass spectrometry

Presenter: Darren Barrington-Light (Senior Product Marketing Manager, Enterprise Chromatography Data Systems, Thermo Fisher Scientific)

Having worked in Chromatography throughout his careerin the fieldsof analytical chemistry, chromatography hardware and computer software,specifically Chromatography Data Systems,for over25years, Darren has a unique understanding of the requirements of organizations that rely on chromatography data to manage their day to day operations. As capabilities have advanced, Darren has worked with clients across multiple industries to show them how Thermo Scientific Chromeleon CDS software can help them to improve their day to day operations and drive fast, informed decisions.

Presenter: Jon Bardsley (Pharma & BioPharma Manager, Thermo Fisher Scientific)

Jon Bardsley has over a decade of experience of small-molecule pharmaceutical DMPK and regulated bioanalytical studies within with large Pharmaceutical environments. His passion for development of robust and accurate analytical methods for high-throughput studies has seen him also gain experience in contract research organizations. Jon sits on the ReidBioAnalyticalcommittee of the Chromatography Society and is a subject matter expert in the bioanalysis community. Following a period as Senior Applications Specialist for Chromatography, Jon now holds the position of Vertical Marketing Specialist for Pharma &BioPharmawithin Thermo Fisher Scientific, with a view to bringing relevant technologies together to help solve customer challenges.