Nitrosamine analysis
Safeguarding health through precision testing for nitrosamines.
At Normec Synergy Health, we understand the urge to ensure patiënt safety and regulatory compliance are non-negotiable. That’s why we’ve expanded our analytical capabilities to include advanced nitrosamine testing. With increasing global compliance on nitrosamine impurities in pharmaceuticals, our laboratory provides the expertise and technology you need to stay ahead ensuring your products meet the highest safety standards.
Why the challenges urges to test for Nitrosamines
Nitrosamines (also known as N-nitroso compounds) are a class of organic chemical compounds containing the nitroso functional group (-N=O). They are formed when secondary or tertiary amines react with nitrosating agents such as nitrites.
These compounds are considered potent genotoxic impurities and may unintentionally form during drug synthesis, formulation, or storage. Even at trace levels, nitrosamines pose potential carcinogenic risks—triggering a strong and ongoing regulatory response worldwide.
Since 2018, regulatory authorities such as the EMA and FDA have issued strict guidance on the assessment and control of nitrosamine impurities, including:
EMA/409815/2020
EMA/189634/2019
FDA Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs (2023)
Manufacturers are required to identify risks, monitor nitrosamine levels, and implement effective controls. Accurate detection and quantification are therefore critical to regulatory compliance, patient safety, and preserving product integrity.
Nitrosamines Analysis via LC-MS/MS: Versatility for Complex Matrices
For non-volatile or thermally unstable nitrosamines, our liquid chromatography tandem mass spectrometry (LC-MS/MS) method offers unmatched versatility. This technique allows for accurate quantification in complex matrices, including biological samples and excipients. Our LC-MS/MS service empowers you to confidently assess nitrosamine levels across a wide range of pharmaceutical products.
Nitrosamine Control Across the Pharmaceutical Lifecycle
Effective nitrosamine control requires attention at every stage of pharmaceutical development
Active Pharmaceutical Ingredients (APIs)
For APIs, the European Pharmacopoeia chapter 2.5.42 provides detailed guidance on analytical procedures and acceptable nitrosamine levels. The EDQM mandates validated testing for certain active substances, with concentrations as low as 30 parts per billion (ppb).
Excipients
While excipients are often overlooked in impurity risk assessments, they can play a critical role in nitrosamine formation. According to the WHO, if an excipient is identified as a probable contributor to nitrosamine generation, it must be controlled and tested accordingly.
Finished Drug Products
For finished formulations, the U.S. Food and Drug Administration (FDA) applies the Acceptable Intake (AI) concept based on the maximum daily dose of the product. For instance, if a drug’s daily dose is less than 880 mg, the nitrosamine limit may be set around 0.03 ppm
Interested in what strategic partnership with Normec Synergy Health can further do for you?