Articles

Strategies to Streamline & Optimize Formulation

To support the growing need for nitrosamine testing, SGS has expanded its volume for nitrosamine testing beyond its current service offering in Mississauga, Canada. SGS has added capacity and instrumentation to offer nitrosamine testing, including drug substance-related impurities (NDSRIs) at its West Chester, PA and Markham, Canada laboratories to allow for expanded capacity for nitrosamine testing, while staying ahead of the curve as regulations continue to evolve.

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Webinar: Lipid-Based Drug Delivery_ Dosage Form Design from Preclinical to First-in-Human

SGS doubled its capacity for nitrosamine testing, accelerating nitrosamine testing for our North American customers

There has been a Growing concern among regulators driving a need for awareness for manufacturers to understand the risk associated with nitrosamines in pharmaceutical and biopharmaceutical products.
In this session of Changing the Conversation with SGS Live, we tackled a variety of aspects of this important issue from the risk associated with nitrosamine contamination to discovery and mitigation of nitrosamine impurities.
Our experts shared the current testing requirements, along with how SGS is helping drug manufacturers along the path of development to ensure their products are free from nitrosamine contamination.


A Dive into Regulatory Requirements and Strategies for Nitrosamine Testing

This article provides an assessment of nitrosamine
contamination specifically in biologics and contrasts the potential risks between these product types.
