Nitrosamines

Two scientists looking at a computer
Medicines
 // August 23, 2023

Part One: Industry examining FDA guidance on nitrosamines...

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.
Mrunal Jaywant
Naiffer Romero, Principal Scientist
Mrunal Jaywant Naiffer Romero
Researcher holding pharmaceuticals in lab
Medicines
 // November 27, 2023

Revisiting the Landscape of Potential Nitrosamines in Pharmaceuticals using CPCA fram...

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.
Naiffer Romero, Principal Scientist
Naiffer Romero
Two scientists looking at a computer
Medicines
 // August 23, 2023

Part One: Industry examining FDA guidance on nitrosamines...

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.
Mrunal Jaywant
Naiffer Romero, Principal Scientist
Mrunal Jaywant Naiffer Romero
Nitrosamine Impurities in Medicines: Preventing history from repeating itself
Medicines
 // March 12, 2021

Nitrosamine Impurities in Medicines: Preventing history from repeating itself...

The presence of objectionable levels of chemical impurities in pharmaceuticals can have serious public health impacts. Not only do they pose a risk of harm to patients, but the discovery of unacceptable levels of impurities in trusted medicines can also undermine public confidence in the quality of drug products. Due to the potentially serious risk to public health, impurities in pharmaceuticals are strictly regulated.
Profile picture for user ed.gump@usp.org
Edwin Gump, PhD