Nitrosamine analysis.

For maximum product safety and compliance.

Do you want to reliably meet regulatory requirements while identifying risks in your active ingredients, excipients, finished drugs, or packaging at an early stage?

We provide reliable analysis – in accordance with GMP and with confidence.

  • Highly sensitive screening analysis: LC-MS/MS and GC-MS for multiple nitrosamines simultaneously.
  • Quantification of specific nitrosamines: In API, finished products, excipients, and packaging.
  • Trace analysis down to the ng/g or ng/mL range: Matrix-dependent and validated.
  • Method development & validation: According to ICH Q2 (R1) – including LOD/LOQ, accuracy, specificity, and much more.
  • Complex matrices: We deliver results with regulatory certainty – even for challenging samples.
  • Added value for your project: Consulting on risk analysis (EMA, ICH M7), strategic planning, CAPA support, fast quotation.

Request an analysis

Let´s talk about your project