Browsing Category
DSM
N-nitrosamine Mitigation with Nitrite Scavengers in Oral Pharmaceutical Drug Products
N-nitrosamines are likely human carcinogens. After N-nitrosamine contaminants were detected in pharmaceutical products in 2018, regulatory authorities set a framework for the risk assessment, testing and mitigation of N-nitrosamines in drug products. One strategy to inhibit the formation of …
Read More...
Read More...
Your visit at CPHI worldwide 2022 in Frankfurt
CPHI worldwide opens its doors again. This year in Frankfurt at the Messe Frankfurt. In two weeks, from 1st to 3rd November, you can finally have a face-to-face chat with visitors and exhibitors again. As usual, InnoPack, P-MEC, FDF, ICSE and BioProduction will be held together with CPHI.
The…
Read More...
Read More...
Antioxidants, a safe and viable Inhibition Strategy for Nitrosamine Formation In Drug Products…
Nitrosamines are potential mutagens and need to be controlled in human drug products. Recently, nitrosamine contamination of high-profile drugs has prompted numerous recalls, and increased regulatory assessments for marketed products, as well as for new drug applications.
There will be three…
Read More...
Read More...
Expert view: 5 things you need to know about nitrosamines in drug formulation
Nitrosamine risk mitigation is front of mind for many drug formulators following the discovery of N-nitrosodimethylamine (NDMA) in valsartan – a commonly used drug in the treatment of high blood pressure and heart failure.
To learn more about the situation, DSM interviewed Prof. Gerhard…
Read More...
Read More...