Nitrosamines: A Hidden Challenge in Drug Manufacturing

Nitrosamines, recognized as carcinogenic, can form at various stages of the drug manufacturing process. These impurities are typically generated when secondary or tertiary amines react with nitrite, especially under acidic or high-temperature conditions. This means nitrosamines can appear during the upstream synthesis of active pharmaceutical ingredients (APIs), in intermediate stages, or even during the final formulation of tablets and capsules. Their presence poses a significant challenge, as even trace amounts in medications can compromise patient safety.

In response to this, regulatory bodies like the FDA and EMA have released stringent guidelines outlining acceptable limits for nitrosamine impurities in drugs. These guidelines have pushed pharmaceutical companies and API contract manufacturers to reevaluate their workflows, raw materials, and reaction conditions to reduce or eliminate nitrosamines. Advanced analytical tools and optimized manufacturing processes are becoming critical to eliminating these contaminants and ensuring regulatory compliance.

At ReactWise, we specialize in process optimization to address challenges like eliminating impurities in existing workflows. Whether you’re dealing with nitrosamines or other critical process hurdles, we help you refine your operations and enhance safety and efficiency.

Curious to learn more? Reach out to us via info@reactwise.com

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