Nasdaq

Aptar’s N-Sorb Nitrosamine Mitigation Solution Accepted to US FDA’s Emerging Technology Program

N-Sorb leverages Aptar CSP Technologies’ proven 3-Phase Activ-Polymer™ platform technology to address the pressing issue of N-nitrosamine impurities in pharmaceuticals. These impurities, classified as ...
JD Supra

FDA Issues Notice on Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities and Requests Comments

Our FDA Compliance & Enforcement Team highlights key takeaways from the Food and Drug Administration’s notice identifying scientific and regulatory considerations for nitrosamine drug ...
JD Supra

New FDA Guidance on Control of Nitrosamine Impurities

On September 1, 2020, the U.S. Food and Drug Administration (“FDA”) released a new guidance document, Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs,[i] following a series of ...
C&EN

Carbon nanotube sensor detects nitrosamines in the air

Detecting N-nitrosamines in air has traditionally been a multistep process: someone must first collect suspect air within solid sorbents or liquid solutions and then ship the materials to a testing ...