Sandrine Picco

Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.

Nine duloxetine recalls since 2024 show why generic drug manufacturers need route-level nitrosamine risk assessment, not end-product testing alone.

Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.

Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.