Nitrosamine analysis.
For the early detection and quantification of potentially carcinogenic nitrosamines.
Would you like to ensure that your API, excipients, finished drugs, or packaging do not contain any unacceptable nitrosamines? For several years now, nitrosamines have been the focus of attention for the EMA and FDA, as they are considered potentially carcinogenic. Even the slightest traces can lead to batch recalls or loss of approval. That is why early and comprehensive monitoring is crucial. We provide reliable analysis – in accordance with GMP and with foresight.
Our services at a glance:
- Highly sensitive screening analyses: We use LC-MS/MS and GC-MS to detect multiple nitrosamines simultaneously. These methods are particularly sensitive and are suitable for rapid risk screening.
- Quantification of specific nitrosamines: We determine defined nitrosamines in APIs, finished products, excipients, and packaging—thus ensuring regulatory compliance.
- Trace analysis down to the ng/g or ng/mL range: Matrix-dependent and validated. This allows us to detect even the smallest quantities before they pose a risk.
- Method development & validation: According to ICH Q2 (R1) – including LOD/LOQ, accuracy, specificity, and robustness. We tailor the method precisely to your product matrix.
- Complex matrices: We deliver results with regulatory certainty, even for difficult samples.
- Added value for your project: We advise on risk analyses (EMA, ICH M7), assist with strategic planning, offer CAPA support, and prepare quotes within a very short time.
This ensures that you are on the safe side when it comes to regulatory audits—and that your product meets the highest quality requirements at all times.
Your advantage: With our expertise, you create transparency and security for regulatory authorities, customers, and patients.
