Rapid Characterization of Impurities

Case study

Impurities in drug products can arise at various time points during the manufacturing process or during storage. Without swift identification to assess potential risk, they can stall critical clinical timelines or cause a product recall. In this instance, our client discovered an impurity during ongoing stability studies that exceeded a qualification limit set forth by ICH guidelines. They needed a partner who could rapidly identify the impurity to determine whether further toxicology studies were required.

To learn how Cambrex’s expert chemists were able to deliver the structural identity to the client within days, download the full case study.