Addressing the Analytical Challenges of Nitrosamine Analysis in Pharmaceuticals

Accurate measurement of nitrosamines in pharmaceuticals such as Metformin is important for end user safety. Nitrosamines are low molecular weight compounds meaning that in-matrix selectivity is challenging for unit mass resolution, quadrupole mass spectrometers. This can lead to false positive results.

The optimized procedure will provide clean samples, method robustness, and enhanced sensitivity for nitrosamine determination in metformin drug substance.

Key learning objectives:

• How high-resolution accurate mass full scan acquisition with sub ppm mass accuracy can help to eliminate false positive results with high sensitivity, giving you confidence in data reporting.
• How to achieve optimal method sensitivity for nitrosamine analysis through method development and optimization.
• How to use Thermo Scientific Chromeleon CDS software for 21 Part 11 CFR compliant MS data acquisition and processing.

Who should attend:

• Analysts, team leaders, data integrity specialist, QA auditors & lab managers in Pharma analytical testing environments.
• Scientists and chemists at the analytical science testing laboratories, CDMOs or pharmaceutical manufacturers.
• Analysts and companies performing nitrosamine analysis in drug products and drug substances.

Presenter: Aaron Lamb (Vertical Marketing Manager, Pharma & BioPharma, Thermo Fisher Scientific)

Aaron is a Pharma & BioPharma Vertical Marketing Manager working in the Chromatography and Mass Spectrometry Division at Thermo Fisher Scientific, UK. He collaborates with Pharmaceutical manufactures, Analytical Testing Labs and is responsible for generating collateral and the planning of Pharma campaigns. Aaron has also worked in industry as an R&D and Pharma Team Leader at Intertek using a multitude of analytical techniques including ion chromatography, GC–MS and LC–MS in health care and pharmaceutical analyses.