Analysis of Genotoxic Nitrosamine Impurities in Pharmaceutical Products using High-Resolution Accurate Mass (HRAM) Mass Spectrometry

Register free: http://www.pharmtech.com/pt_w/genotoxic

Event Overview:
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.

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.

Here we will describe analytical options to solve nitrosamine analysis challenges.

Key Learning Objectives:

• Why is the analysis of genotoxic impurities important?

• How can cost-sensitive genotoxin impurity analysis be delivered using high-resolution mass spectrometry?

• Can high-resolution mass spectrometry be easily implemented under GMP conditions?

Speaker: Jon Bardsley, Pharma & BioPharma Manager, Thermo Fisher Scientific

Time and Date: Wednesday, May 13, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after final airing May 13, 2021

Sponsor: Thermo Fisher Scientific

Register free: http://www.pharmtech.com/pt_w/genotoxic