Nitrosamine

Abstract NNitrosamine risk assessment and control are essential components of pharmaceutical drug development and product evaluation. Nitrites present in excipients...

BASF has news for drug formulators! They introduced a new ‘Nitrosamine Risk Assessment and Mitigation’ app in ZoomLab®, their Virtual...

Abstract N-nitrosamine compounds have long been known for their carcinogenic properties, but they came into the focus of the pharmaceutical...

Since 2018 the risk of nitrosamine impurities in medicinal products has become a critical concern for pharmaceutical manufacturers and regulators...

Abstract N-nitroso-bisoprolol (NBP) is a nitrosamine drug substance-related impurity (NDSRI) of bisoprolol, which is used to treat cardiac diseases since...

Abstract Nitrosamine impurities have garnered recent attention due to their presence in pharmaceuticals and their mutagenic risks. Recent studies have...

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...