EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of USP 1469 testing. This section provides users with high-level guidance for controlling or reducing unsafe nitrosamine levels.
Nitrosamines are chemicals commonly found in water and food. Smoked and grilled meats, dairy products and vegetables. Everyone is exposed to some amount of nitrosamines.
However, since nitrosamine impurities are possible human carcinogens, even traces of their presence in drugs pose high safety risks for patients.
The presence of nitrosamines in multi-drug products with active substances with different chemical structures indicates that in addition to the active substance itself, other components of the drug products may also be sources.
This section discusses the general approach to deciding when testing is required, based on the risk assessment and control strategy.
A general section is better positioned as an overarching standard for addressing nitrosamine impurities in various drug products or ingredients.
EUROLAB assists manufacturers with USP 1469 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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