Impurities

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
Child taking cough syrup
Supply Chain
 // September 21, 2023

Ensuring Product Safety: U.S. FDA Guidance on Testing High-Risk Drug Components for D...

Excipients, or inactive ingredients, in a drug formulation are critical components, comprising up to 90% of a drug formulation by volume and serving important functions such as improving stability and increasing bioavailability for targeted drug delivery. However, with so much focus on the quality of active ingredients in the complex pharmaceutical supply chain, the quality of inactive ingredients is, at times, overlooked.
Y
Catherine Sheehan, DRSc., MS, MS
J
Yognandan Pandya Dr. Catherine Sheehan Jenny (Tong) Liu
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