SGS has doubled its capacity for nitrosamine testing, accelerating nitrosamine testing for our North American customers.
Since the discovery of nitrosamines in pharmaceutical products, the US Food and Drug Administration (US FDA), the European Medicines Agency (EMA) and Health Canada have all published requirements and limits related to nitrosamine contaminants with a recommended completion date for the testing in both Canada and the US on or before October 1, 2023. These requirements apply to both new products and products already on the market.
As a result, our customers are facing a new challenge: finding efficient, reliable partners to carry out testing for nitrosamine impurities in products and active pharmaceutical ingredients (APIs) through established and customized methods.
Expanding our testing capacity
To support this growing need, we have expanded our volume for nitrosamine testing beyond our current service offering in Mississauga, CA. We have now added capacity and instrumentation to offer nitrosamine testing, including drug substance-related impurities (NDSRIs) in our West Chester, PA and Markham, Canada laboratories. This allows us extend capacity for nitrosamine testing, while staying ahead of the curve as regulations continue to evolve.
At all three sites we have invested in new, state-of-the-art equipment and new capabilities to improve our ability to support fast and accurate nitrosamine testing. These include:
- New equipment, including a Sciex 6500 and equipment to support LC-MS and LC-MS/MS testing at both sites. Equipment for GC-MS testing (using a triple-quadrupole mass spectrometer) has also been added to the Markham site
- Expanded dedicated teams with extensive expertise in nitrosamine testing
Both laboratories can detect impurities at the low levels required by regulatory authorities, (< 1 ppb). Thanks to these improvements, we now have a network of three laboratories across the United States and Canada, with nitrosamine testing capability: our West Chester, Markham and Mississauga facilities are ready to support more of our pharmaceutical customers.
Using this approach, we can offer the full scope of nitrosamine testing solutions, including method development, validation and transfer, as well as other related mass spectrometer capabilities that complement nitrosamine testing.
MS-based techniques are amongst the most widely used and effective methods for nitrosamine testing, providing the necessary sensitivity and selectivity to obtain recommended LOD/LOQ levels and specifications in a variety of product types.
"There is a need for manufacturers to understand the risks associated with nitrosamines, as well as the testing requirements for their products, to ensure patient safety and meet the impending deadline", says Niveen Mulholland, Vice President of Drug Development for SGS North America. "That's why we've invested in this significant expansion of our capabilities and expertise to give our customers the support they need to avoid disruption in their projects, helping them deliver safe, effective products to market faster."
The expansion of these two sites (alongside the many SGS sites in North America, Europe and Asia that are already conducting nitrosamine testing) allows us to deliver support for nitrosamine testing at unprecedented levels. Our global network of experts are uniquely positioned to develop analytical solutions that identify and quantify all nitrosamine contaminants – including the highly complex tests required to detect NDSRIs.
These new capabilities, combined with our extensive expertise and experience in the field, make us the perfect partner to help our clients navigate these changing regulations.
For further information, please contact:
Vice President of Drug Development
SGS North America
t: +1 551 245 1896
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