With regulators highlighting the importance of detecting and preventing unacceptable levels of nitrosamine impurities in products, it is easy to conclude that requesting a full nitrosamines analysis for your pharmaceutical is the best solution. However, this approach could involve a lengthy method development and validation process, particularly in complex matrices with low analytical thresholds.
But are there better methods available?
By utilising unique chemistry and formulation, it is possible to target the most likely occurring nitrosamines within a product, potentially describing the risk better and reducing the complexity and time of laboratory analysis. Join RSSL Technical Expert Daniel Nicolau for this insightful webinar, where he will discuss:
- The challenges of method development for nitrosamines
- Focused description of the risk nitrosamines pose in specific products
- Generating the right analytical date to better describe the risk
Find out more and register: www.rssl.com/news-and-events/events/2021/nitrosamines-analysis-webinar