SGS Nitrosamine Impurities Testing

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Identify Nitrosamines in Pharmaceutical Products to Ensure Patient Safety

In response to nitrosamines present in pharmaceutical products, the US Food and Drug Administration (US FDA), the European Medical Agency (EMA) and Health Canada have published requirements and limits related to nitrosamine contaminants.

As a pharmaceutical manufacturer, you must now take a proactive approach to risk assessment and mitigation of these genotoxic contaminants within your global supply chain.

SGS can detect nitrosamines impurities in your pharmaceutical products, helping you to ensure product and patient safety, as well as compliance with US FDA, EMA and Health Canada requirements.

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What are Nitrosamines?

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SGS Nitrosamines Testing

Our solution

LC-MSMS Platform Method

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Identify Nitrosamines Traces

Our method

Why SGS?

Your partner

Our Library

Expert Info

What are Nitrosamines?

Nitrosamines are a class of compounds with a chemical structure of a nitroso group bonded to an Amine (R1N(-R2)-N=O). Nitrosamine compounds are potent genotoxic substances and some are classified as probable or possible human carcinogens.

SGS Nitrosamines Testing Solutions

To assure the safety of drug products, we can verify the status of your products and protect patients. With fast turnaround times and the most effective test methods currently on the market, we can quickly and efficiently identify any issues, such as medicine impurities, enabling you to take remedial action swiftly.

LC-MSMS Platform Method

SGS has developed a test method, based on LC-MSMS, to detect the presence of nitrosamine traces in drug products, raw materials and active pharmaceutical ingredients (APIs), at recommended LOD/LOQ levels and specifications.

Regulatory agencies are recommending that all manufacturers and providers test their products to protect patients and ensure that effective measures are taken to prevent these impurities from being present in medicines.

Identify Nitrosamines Traces

We can help you:

  • Identify nitrosamine traces in drug products, raw materials and active pharmaceutical ingredients (APIs)
  • Protect patients
  • Ensure Product Safety

Why SGS?

As the world’s leading inspection, verification, testing and certification company, we offer longstanding expertise and the resources of an international network of laboratories and clinical trial facilities.

We have substantial expertise in developing methods for identifying the presence of NDMA and other nitrosamines in pharmaceutical products. Our experience in optimizing extraction procedures allows us to apply these methods to drug products, active pharmaceutical ingredients (APIs) and raw materials.

Our service integrates a harmonized methodological approach with flexible management of capacity and capability requirements. We offer a variety of partnership models that allow collaboration while using the resources of the SGS global network.

Our Library

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Nitrosamines Webinar

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Technical Paper

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SGS Nitrosamines Brochure

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