Скачать или смотреть Emery Pharma Presentation at Gilead Sciences. For full presentation, see the description below:

We had the great honor of being invited speakers Gilead Sciences thanks to the Analytical Chemistry group, to present on a matter of urgent global importance: nitrosamine contamination in pharmaceuticals.

Together with my colleague, Dr. Ryan Cheu, Director of Chemistry at Emery Pharma, we shared insights on the evolving risk of nitrosamines, beginning with landmark cases from 2018—Valsartan, where a change in synthetic route led to contamination, and Zantac, where the molecule itself degraded into NDMA.

Our talk focused on:

How to do risk analysis for volatile Nitrosamines as well as NDSRI’s.

The metabolic activation of nitrosamines via CYP enzymes, which determines their potential carcinogenicity

Practical approaches in detection, method validation, and quality control

Root cause analysis and structural risk assessment strategies

We were thrilled by the strong engagement—over 60 Gilead scientists participated in the session—and the active discussion around regulatory expectations and upcoming deadlines.

With the FDA’s August 1st, 2025 deadline for nitrosamine risk assessment, there’s increasing pressure on both marketed and pipeline products. The FDA may grant extensions if scientifically justified—but proactive risk evaluation is key.

Please feel free to reach out if you’d like to discuss your nitrosamine strategy, testing, or regulatory support. We look forward to collaborating.

An older Nitrosamine presentation by Dr. Ron Najafi can be viewed here:

   • Nitrosamine in Pharmaceutical Products? A ...  


#Nitrosamines #DrugSafety #MassSpectrometry #Pharma #GileadSciences #EmeryPharma #RegulatoryAffairs #AnalyticalChemistry #FDACompliance #NDMA #CYP450

About Emery Pharma:
Emery Pharma is deeply committed to advancing public health and exclusively focuses on projects that enhance the well-being of both individuals and the environment. As a comprehensive contract research laboratory, Emery Pharma provides extensive support across the entire spectrum of pharmaceutical development, covering small molecule drugs, biologics, biosimilars, gene therapy, botanicals, and more.

Emery Pharma's array of premium services includes analytical and bioanalytical solutions, microbiology and cell biology services, drug and impurity characterization, and comprehensive R&D with cGMP/GLP support. The Emery Pharma team excels in customizing innovative solutions tailored to the unique requirements of each client. They seamlessly oversee the entire process, from initial drug discovery to thorough data analysis and insights generation. Their expertise allows them to tackle scientific challenges proactively, ensuring clients avoid unnecessary setbacks.

Emery Pharma's accomplished chemists and biologists harness state-of-the-art technology, encompassing cutting-edge tools such as high-resolution mass spectrometry (Orbitrap), triple quad LC-MS/MS, GC-MS, preparative HPLC, and 400 MHz multinuclear NMR.

For further details, please don't hesitate to reach out to Emery Pharma at [email protected] or explore their website at:
https://emerypharma.com/