Nitrosamines

Monitor, control, and prevent nitrosamine impurity contamination

Nitrosamines creating alarm in our industry

Recent reports have identified well-known drug products containing unacceptable levels of nitrosamine impurities. Consequences of the contamination have included drug recalls, warning letters, and drug shortages, resulting in loss of both revenue and consumer confidence.

New regulations necessitate more rigorous controls

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

Can your technology easily detect the lowest impurity levels?

Minimize your risk of missing a nitrosamine, other GTI, or potentially mutagenic impurity (PMI) by using Waters' most sensitive LC-MS technology and application expertise.

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  • Overview
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Webinar: How to Avoid the Next Nitrosamine Crisis
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Nitrosamine Impurities: The Need to Verify
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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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