Elemental impurities testing is challenging due to the variety of elements and complex analytical methods. Accurate quantification and identifying impurity sources pose difficulties. Despite challenges, it ensures product safety. Carefully selecting methods and minimizing impurities is crucial. Failure to detect impurities can be catastrophic, causing health issues. At Sannova, we specialize in testing common elemental impurities, meeting regulatory standards and safeguarding patients and the environment.
Nitrosamines, a class of probable human carcinogens, can lurk undetected in pharmaceutical products. Their presence, though minute, demands the utmost vigilance. These impurities are often present at trace levels, requiring sophisticated analytical techniques for reliable detection and quantification. Sannova’s nitrosamine testing services offer the combination of speed and accuracy to ensure patient safety and regulatory compliance.
Our team of experts leverages state-of-the-art instrumentation and meticulously crafted methodologies to identify and measure even the faintest nitrosamine signals. We have successfully tested over 170 products and APIs for nitrosamines, extending our capabilities to a wide range of compounds, including the latest class of nitrosamines known as nitrosamine drug substance-related impurities (NDSRIs).
Choose Sannova for exceptional quality, personalized services and excellent results, all delivered as quickly as our commitment to excellence allows.