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Abstract The ICH M7 guidance “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk”...
We are glad to present our new webinar in collaboration with our partner Shin-Etsu: The Role of Excipients in Determining...
Abstract Many studies are being conducted on the detection of nitrosamine impurities in solid formulations. However, research on semi-solid formulations...
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...
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