Nitrosamines : no one-size-fits-all method. A testing strategy tailored to your product.

📃 Since 2019, the regulatory framework on nitrosamines in pharmaceutical products has kept evolving. Systematic risk evaluation, confirmatory testing, marketing authorization variations, lifecycle management : the ICH M7 guidelines have progressively expanded these requirements for manufacturers.

But beyond the regulatory text, the real challenge is analytical : detecting genotoxic impurities down to 18 ng/day (CPCA 1 categories) in real matrices, while controlling matrix effects and preparation artifacts that can distort results.

Our support, in 4 steps

1. Risk review : selecting the analytical approach suited to your regulatory dossier
2. Method development : custom method on your real matrices (API, excipients, finished forms)
3. Fit-for-purpose validation : confirmation and documentation designed for your regulatory submissions, with a justification of the analytical choice supporting your marketing authorization dossiers
4. GMP QC analysis : support for your process optimization through clinical and commercial batch analysis

A preventive approach

Beyond regulatory analysis, CEBIPHAR also supports manufacturers upstream, as part of a preventive strategy : manufacturing technical batches with varying antioxidant content, stability testing, and comparative evaluation of the antioxidant’s protective effect on nitrosamine formation.

🤝 Why choose CEBIPHAR for your nitrosamine testing ?

• Compliance : methods aligned with EMA, FDA, ICH M7, European Pharmacopoeia and USP standards, delivering defensible results at every stage of the regulatory process
• Agility : rapid method development with controlled timelines, even for non-standard matrices
• Science : advanced LC-MS/MS expertise, mastery of matrix effects and trace-level limits of quantification (LOQs)
• Trust : reports documenting results and the analytical rationale behind every decision

📩 Have a nitrosamine project ? Talk to one of our experts to define the right approach together.