SGS Expands Nitrosamine Testing Capacity

FDA, the European Medicines Agency (EMA), and Health Canada have all published requirements and limits related to nitrosamines in pharmaceutical products and contaminants with a recommended completing date for the testing in both Canada and the United States on or before Oct. 1, 2023. Additionally, these requirements apply to both new products and products that are already on the market.

Due to the challenges of finding reliable partners to carry out testing for nitrosamine impurities in products and APIs through established, customized methods, SGS has expanded their volume for testing to West Chester, PA, and Markham, Canada laboratories, on top of their current service offering in Mississauga, CA.

The three sites have new, state-of-the-art equipment and new capabilities to improve the company’s ability to support nitrosamine testing, according to a press release, which 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).
• Expanded dedicated teams with extensive expertise in nitrosamine testing.

"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, in a press release. "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."

Source: SGS