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 ...

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

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 ...

Nitrosamines are classified as potential cancer-causing agents. The chemicals have been found in several prescription drugs in recent years, prompting recalls. Most recently, Pfizer issued a voluntary ...

Selected ion flow tube mass spectrometry (SIFT-MS) greatly simplifies quantitative analysis of volatile nitrosamine impurities in drug products. It provides a three-fold throughput advantage and ...

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 ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

The Food and Drug Administration (FDA) has outlined industry guidance for Control of Nitrosamine Impurities in Human Drugs (Rev 1-Feb2021) authorization holders (MAHs) on risk measures to tackle ...

The FDA has designated this a Class II recall. Over 7100 bottles of duloxetine have been recalled due to the presence of a nitrosamine impurity, N-nitroso-duloxetine, according to the Food and Drug ...

Ascend Laboratories, maker of generic dabigatran etexilate, is recalling 10 manufacturing lots of the oral anticoagulant because of an unacceptably high level of a possible carcinogen, according to a ...

My research focuses on the interface of environmental analytical chemistry, treatment processes, and reactor engineering. I am continuing to study a group of harmful compounds, N-nitrosamines, as ...