Navigating nitrosamine impurities: An in silico approach to risk assessment

In the ever-evolving landscape of pharmaceutical development, ensuring the safety and efficacy of medications is paramount. One of the emerging challenges in this field is the detection and management of nitrosamine impurities—potentially carcinogenic compounds that can form during drug manufacturing. To address this, having a robust workflow for nitrosamine impurity risk assessments is essential.

In our nitrosamine risk assessment workflow, we delve into the significance of structured workflows in identifying and mitigating nitrosamine risks. We explore the in silico tools that are advancing this process, providing pharmaceutical companies with the means to conduct robust assessments. In addition, how these tools leverage computational power to predict and analyse potential impurities, offering a proactive approach to risk management.

For many, this workflow begins with the question:

Is there the possibility of nitrosamine formation?

Objective: To identify APIs and finished products at risk of N-nitrosamine formation during manufacturing.

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If the risk of nitrosamine formation is identified, you may then ask:

Is the nitrosamine potentially mutagenic?

Objective: To confirm if the impurity is in the ICH M7 cohort of concern and assess mutagenic potential.

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You will then need to determine:

What is the acceptable intake (AI) limit?

Objective: To derive specification limits from AIs and maximum daily dose of product.

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Finally, you may look to ask:

Is the nitrosamine removal shown through purge factor calculation?

Objective: To assess whether risk of nitrosamine formation in API manufacturing process is negligible through purge assessment.

Find out more about in silico nitrosamine impurity risk assessments here.

If you are currently carrying out nitrosamine assessments, and are interested in finding out more about using in silico solutions, speak to a member of our Applied Sciences team today - contact us here.