Nitrosamine analysis

Monitor, control, and prevent nitrosamine impurity contamination

Unacceptable levels of N-nitrosamine impurities, which may increase the risk of cancer, have been found in some types of medications. This resulted in drug recalls, warning letters and drug shortages.

Whether your company has been directly impacted or not, proposed future EMA and FDA regulations will require more stringent detection of these genotoxic impurities (GTIs) for products sold in their markets.

Discover how we can help you identify and quantify nitrosamines and other genotoxic impurities today.

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  • Overview
  • Literature
  • Application Notes

Webinar: How to Avoid the Next Nitrosamine Crisis
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Mutagenic Impurity Risk Assessment Throughout the Development and Manufacturing Process
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The Current Concerns About Genotoxic Impurities Found in Commonly Used Prescription and Over The Counter Pharmaceutical Drugs:
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Method Lifecycle Management: Keep Your Method Fit for Life.
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The Nitrosamine Crisis Podcast - Controlling Risk: An Industry Leader's Perspective
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