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Nitrosamines Impurities Analytical Methods Repository

Category dedicated to frequent ask questions curated by our Nitrosamine Exchange ambassador members.

Access past or future events on Nitrosamine. Feel free to post links that will be helpful to the community.

Discuss about N-nitrosamines chemistry.
Nitrosamines can be form form amines and nitrosating agents under certain reactions conditions.

Discuss about N-nitrosamines Limits
Having identified risk and sources of nitrosamines, Regulators have established ‘Acceptable Intake Limits’ for manufacturers to comply as part of their overall recommendations.

N-Nitrosamine sources:
APIs, Excipients, Solvent/Water, Processes, Storage, Packaging,

Discuss about Risk Assessment Strategies and Tools.
A risk assessment should be conducted to determine the materials that contribute to the potential for inclusion of Nitrosamines in the drug product. All potential sources for the introduction should be consider in the risk assessment.

The development of analytical methodology for potential genotoxic impurities (GTIs) assessment can be time consuming and laborious. While there are several approaches to method development, having a discussion forum to discuss challenges and best practices can help streamline the evaluations. This ‘Confirmatory Testing’ category provides a forum for: 1) Asking lots of questions; 2) Share your work, 3) Give plenty of feedback.

Discuss in-depth emergence of new scientific evidence around nitrosamines, risk factors and root cause.

International Government and Regulatory Affairs
Space dedicated to sharing recent regulatory updates directly on Nitrosamines Impurities