Presentation at Exelixis Pharma. “Nitrosamine Challenges in Drug Development: Are You Prepared?” скачать в хорошем качестве

Presentation at Exelixis Pharma. “Nitrosamine Challenges in Drug Development: Are You Prepared?”

We had the pleasure of presenting at Exelixis Pharmaceuticals, thanks to the Analytical Chemistry group, on a topic of growing global concern: nitrosamine contamination in pharmaceuticals. Alongside my colleague, Dr. Ryan Cheu, Director of Chemistry at Emery Pharma, we discussed the shifting landscape of nitrosamine risks—starting with two pivotal cases from 2018: • Valsartan, where a change in the synthetic route led to contamination • Zantac, which was later shown to degrade into NDMA under certain conditions Our talk focused on several key areas: • Risk analysis for volatile nitrosamines and nitrosamine drug substance-related impurities (NDSRIs) • The role of CYP enzymes in the metabolic activation and carcinogenicity of nitrosamines • Analytical strategies for detection, method validation, and quality control • Root cause investigations and structural risk assessment approaches The session brought together more than 60 scientists from Exelixis and led to a dynamic conversation about evolving regulatory expectations and industry best practices. As regulatory scrutiny around nitrosamines continues to grow, it’s essential for drug developers to stay ahead—by proactively evaluating risk, developing robust analytical methods, and ensuring compliance through rigorous impurity profiling. If you’re rethinking your nitrosamine strategy or seeking analytical and regulatory support, our team is here to help. 🎥 Watch a previous talk on the subject by Dr. Ron Najafi:    • Nitrosamine in Pharmaceutical Products? A ...   ⸻ #Nitrosamines #PharmaceuticalTesting #RegulatoryCompliance #ExelixisPharmaceuticals #EmeryPharma #AnalyticalChemistry #MassSpectrometry #NDMA #CYP450 ⸻ About Emery Pharma Emery Pharma is a mission-driven contract research organization focused on advancing public and environmental health. We support every stage of pharmaceutical development—across small molecules, biologics, biosimilars, gene therapies, and botanicals. Our core services include: • Analytical and bioanalytical testing • Microbiology and cell biology • Impurity profiling • Full-spectrum R&D support under cGMP/GLP standards Our technologies include: • High-resolution Orbitrap mass spectrometry • Triple quadrupole LC-MS/MS • GC-MS • Semi-preparative HPLC • 400 MHz multinuclear NMR 📧 [email protected] 🌐 emerypharma.com