New nitrosamine limits aren’t just a regulatory update - they’re forcing a fundamental rethink of pharmaceutical process design to stay compliant.

New nitrosamine limits aren’t just a regulatory update - they’re forcing a fundamental rethink of pharmaceutical process design to stay compliant, reduce review delays, and protect product timelines.

Here is how we can help:

In May 2025, the FDA introduced stricter guidelines on acceptable intake limits (AIs) for nitrosamines in drugs, including nitrosamine drug substance-related impurities (NDSRIs), due to their carcinogenic risk.Using a carcinogenic potency categorization approach, compounds are now grouped by risk level - with AI thresholds as low as 26.5 ng/day for some.

That means many “optimized” processes no longer meet the new FDA compliance and must be re-evaluated.

Nitrosamines form when secondary or tertiary amines react with nitrosating agents like nitrites under acidic conditions.

This can happen during API synthesis, quenching steps, or even in storage - especially if solvents or reagents contain trace nitrites.

It’s often subtle, yet highly regulated.For pharma companies and CDMOs, this shift means more than just analytical screening.

It requires teams to rethink and reoptimize core chemical processes to meet new safety standards - while still balancing yield, throughput, cost, sustainability, and timelines.

At ReactWise, we help R&D teams do exactly that.Our platform enables efficient multi-objective optimization using advanced machine learning, helping you identify experimental conditions that suppress nitrosamine formation, minimize other impurities, and maximize performance.

R&D teams often say, "…, but our chemistry is too complex." but that’s precisely where machine learning shines.

ReactWise is built for real-world, messy data - and helps chemists make sense of it, fast.

We believe regulatory change can be a catalyst for innovation - not a bottleneck.I

f you’re facing pressure to update legacy processes in light of the new nitrosamine legislation - or just want to explore how AI-driven process optimization can support compliance get in touch.

We’re here to help you adapt quickly and stay ahead.