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Nitrosamine
Nitrocellulose blister material as a source of N-nitrosamine contamination of pharmaceutical drug…
The recent focus of pharmaceutical regulatory authorities has been oriented towards the mitigation of carcinogenic N-nitrosamines in drug products and different sources of N-nitrosamines have been revealed. Within this work, the elucidation of a further source of N-nitrosamines in drug products is…
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What Makes a Potent Nitrosamine? Statistical Validation of Expert-Derived Structure–Activity…
The discovery of carcinogenic nitrosamine impurities above the safe limits in pharmaceuticals has led to an urgent need to develop methods for extending structure–activity relationship (SAR) analyses from relatively limited datasets, while the level of confidence required in that SAR indicates that…
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N-Nitrosodimethylamine formation in metformin hydrochloride sustained-release tablets: effects of…
In recent years, nitrosamines have been discovered in some types of drug products that becomes a current regulatory hotspot, and have attracted a lot attention from both regulatory authorities and industry. This manuscript provided an industry perspective on the nitrosamines research. A liquid…
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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…
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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…
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