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Pharma Excipients proudly present the new webinar with Roquette and Catalent: Optimizing Pharmaceutical Formulations: Strategies for Improving Stability and Minimizing...
MEGGLE published a study and an update on the topic of "Risk Mitigation of Nitrosamines Formation in Drug Products:...
Abstract N-nitrosamines are a class of compounds belonging to the “cohort of concern” and characterized by the linkage of a...
Summary The discovery of N-nitrosamine impurities in pharmaceutical products has raised serious quality concerns, particularly in metformin products, which are...
This newsletter by Fuji Chemical Industries highlights how Fujicalin®, a low nitrite content Dicalcium Phosphate Anhydrous (DCPA), can support manufacturers...
See an overview on Roquette´s low nitrite excipients and APIs and what they can do for your formulations: The Eye...
N-Nitrosodimethylamine (NDMA) and other nitrosamines, are categorized as probable human carcinogens, and were first identified in drug products containing valsartan...
See the nice infographic prepared by IPEC Federation on the hot topic of Nitrosamine Risk Determination: THE BACKGROUND N-nitrosamines...
Abstract The mitigation of nitrosamine formation in drug products has been studied and approaches such as using formulations with pH...
In this paper, the authors introduce a method that combines ion exchange chromatography with a easier-to-perform, simpler one-step post-column derivatization...
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