Medicines

USP’s Naiffer Romero has teamed up with researchers at LHASA Limited, AstraZeneca, Sai Life Sciences and Merck for collaborative research on nitrosamines impurities that was published this month in the Journal of Pharmaceutical Sciences. Quality Matters recently sat down with Romero, who leads USP’s Nitrosamines Exchange, to learn more about the new research and what it means for the field.

Nitrosamine impurities in pharmaceutical products have been making major headlines recently, as this year has marked the fifth anniversary since they were first detected at unacceptable levels in some blood pressure medications and – even more importantly – due to a flurry of new regulatory activity taking place around the globe this summer, including by the U.S. Food and Drug Administration (FDA). In this two-part Quality Matters blog series, we take a look at the FDA’s recent guidance on nitrosamines and what it means for industry.