Risk evaluation of nitrosamines in pharmaceuticals

If a risk is identified for an active substance, marketing authorisation holders should proceed with confirmatory testing of the finished products identified to be at risk of N-nitrosamine formation. Precautionary testing to ensure patient safety are required for special drug products while the investigation is still ongoing.

The GMP-analytics experts at DSI-pharm support marketing authorisation holders to be in line with the requirements. A tailored solution is needed to overcome the hurdle of matrix effects and the low limit of quantifications.

“Our lab is capable to perform LC-MS or GC-MS depending on the matrix. Both methods are validated and can easily be adapted to all products. If necessary a product-specific full-validation according ICH-guidelines is performed. This is how we ensure the quality of your product!” explains Serap Acikgöz, Managing Director at DSI-pharm.

About DSI-pharm

DSI-pharm is a GMP certified laboratory which supports its clients in regards of pharmaceutical quality control – quickly, reliably and without complications. As a partner of pharmaceutical industry DSI-pharm shoulders responsibility for R&D projects and operates as an extension of our clients’ quality control (QC) workbench.
Please find further information at https://www.dsi-pharm.de