Confidence in Process: A Fully Automated Solution for Nitrosamine Impurity Analysis Applicable to LC-MS and GC-MS

Since 2018 Nitrosamine analysis in drug products such at Metformin have a been a highly discussed topic following an announcement from regulatory bodies world-wide that every product destined for human-use should be assessed for nitrosamine impurities. Challenges with sensitivity, complex matrices and maintaining regulatory compliance are nothing new, however here scale is also a challenge. The imposed requirements meant that testing is mandatory for any product deemed at risk to contain nitrosamines, including all large-scale production of existing products.

By combining the right instrumentation and tools the sensitivity and selectivity requirements can be met, but in order to make this scale manageable in established QC laboratories new technology can be assessed to automate the sample preparation process. Not only does this provide a higher throughput capability, but mitigates against human error and inconsistency. Furthermore being able to process samples with both an LC-MS and GC-MS endpoint with ether on-line or off-line extraction can have a dramatic impact on consistency and productivity, quickly making the product assessment, and determining the validity of the result, mitigating agist false positive results.

Key learning objectives:

• Discussion around the challenges of nitrosamine impurity analysis
• Exploration of a qualified automated approach to product testing
• Simultaneously prepare sample for LC-MS and GC-MS for confirmatory testing

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: Giorgio Blom (Senior Scientist, AstraZeneca)

Giorgio Blom is a Senior Scientist at AstraZeneca UK working in Pharmaceutical Technology and Development focusing on trace analysis. He has developed various trace analysis methods for the analysis of nitrosamines and amines in drug substance and drug products with a focus om automation for the past two years. Prior to that, Giorgio worked as an Analytical Development Chemist at Carbogen Amcis, developing a variety of analytical procedures to control chemical manufacturing activities. Giorgio obtained his degree in Chemistry with a major in Forensic Science from Avans University in the Netherlands and obtained his PhD in the field of Forensic Taphonomy under the supervision of Professor John Cassella.