Date(s) - 13/05/2020
5:00 pm - 6:00 pm
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?
Who Should Attend:
- Laboratory directors
- Technology leaders
- Study directors
- Principal scientists
For questions please contact Martha Devia: firstname.lastname@example.org