Uploaded July 2025 | Updated September 2026, 2 weeks ago
Honored to Present at Exelixis on Nitrosamine Impurities
We had a wonderful day at Exelixis Pharmaceuticals, where we were once again invited to speak on the critically important topic of nitrosamine impurities in drug substances and drug products.
Nitrosamines are among the most potent carcinogens found in pharmaceuticals. For many of them, the FDA has set extremely low acceptable intake limits—ranging from 96 nanograms to as low as 26 nanograms per day—nearly 1,000 times lower than other classes of carcinogens.
This issue came to light in 2018 with the detection of NDMA (N-Nitrosodimethylamine) in Valsartan, and again in 2019 with findings in Ranitidine (Zantac®). Since then, the science and regulation around nitrosamines have rapidly evolved.
With the FDA’s August 1, 2025 deadline for nitrosamine risk assessments, both marketed and investigational drug products must undergo thorough evaluation.
At Emery Pharma, we have significant experience in:
• Volatile nitrosamines, which often have sub-nanogram safety thresholds
• Nitrosamine Drug Substance Related Impurities (NDSRIs), where structure and CYP-mediated activation determine carcinogenic risk
We were honored to share our work and insights with the talented team at Exelixis. Many thanks to Dr. Katie Guggenheim for hosting us and to David Liu and the analytical sciences group for their warm welcome and thoughtful discussion.
🔗 Learn more: emerypharma.com
#NitrosamineImpurities #EmeryPharma #PharmaceuticalScience #DrugSafety #FDACompliance #RiskAssessment #NDMA #NDSRI #AnalyticalChemistry #LCMS #PharmaRegulations #EmeryPharmaExperts #NitrosamineAnalysis
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 info@emerypharma.com or explore their website at:
emerypharma.com
Honored to Present at Exelixis on Nitrosamine Impurities
We had a wonderful day at Exelixis Pharmaceuticals, where we were once again invited to speak on the critically important topic of nitrosamine impurities in drug substances and drug products.
Nitrosamines are among the most potent carcinogens found in pharmaceuticals. For many of them, the FDA has set extremely low acceptable intake limits—ranging from 96 nanograms to as low as 26 nanograms per day—nearly 1,000 times lower than other classes of carcinogens.
This issue came to light in 2018 with the detection of NDMA (N-Nitrosodimethylamine) in Valsartan, and again in 2019 with findings in Ranitidine (Zantac®). Since then, the science and regulation around nitrosamines have rapidly evolved.
With the FDA’s August 1, 2025 deadline for nitrosamine risk assessments, both marketed and investigational drug products must undergo thorough evaluation.
At Emery Pharma, we have significant experience in:
• Volatile nitrosamines, which often have sub-nanogram safety thresholds
• Nitrosamine Drug Substance Related Impurities (NDSRIs), where structure and CYP-mediated activation determine carcinogenic risk
We were honored to share our work and insights with the talented team at Exelixis. Many thanks to Dr. Katie Guggenheim for hosting us and to David Liu and the analytical sciences group for their warm welcome and thoughtful discussion.
🔗 Learn more: emerypharma.com
#NitrosamineImpurities #EmeryPharma #PharmaceuticalScience #DrugSafety #FDACompliance #RiskAssessment #NDMA #NDSRI #AnalyticalChemistry #LCMS #PharmaRegulations #EmeryPharmaExperts #NitrosamineAnalysis
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 info@emerypharma.com or explore their website at:
emerypharma.com
