Contributing to Nitrosamine Science: Resolian’s Role in Beta-Blocker NDSRI Research

Contributing to Nitrosamine Science:
Resolian’s Role in Beta-Blocker NDSRI Research

Nitrosamines continue to be a critical concern across the pharmaceutical sector, making robust control strategies essential for both drug substances and
drug products.

We’re pleased to be named in a recently published paper exploring nitrosamine formation in beta-blocker drug products and to share our perspective on the work below.

At Resolian, we work closely with our customers to build a deep understanding of nitrosamine formation and risk. In this study, our scientists applied their expertise in nitrosamine analysis to quantify a nitrosamine drug substance-related impurity (NDSRI) at trace levels in beta-blocker tablets. Using a validated LC-MS/MS method, high-quality data was generated from stored drug product samples.

The experimentally measured nitrosamine levels were then compared with predictions from a kinetic model. The results show the model is biased towards overestimation during storage, demonstrating its value as a conservative and effective tool for nitrosamine risk assessment and prioritisation.

🔗 Read the paper: https://doi.org/10.1016/j.xphs.2025.104067

RESOLIAN:
YOUR Nitrosamine Testing 

We help drug developers manage nitrosamine risk with expert LC‑MS/MS analysis and validated methods.

  • Trace-level testing of APIs, excipients, and finished products
  • Regulatory-aligned strategies following ICH M7(R1) and other global guidance
  • Collaborative support to integrate testing into your development and quality processes

Trusted insight, high-quality data, confident decisions.

Ready to Advance Your Nitrosamine Strategy?

Your partner in nitrosamine science, testing and compliance.
Resolian brings deep experience in nitrosamine analysis across pharmaceutical materials, formulations and marketed products.

Our experts work collaboratively with development teams to design, validate and execute analytical strategies that deliver high‑confidence nitrosamine data tailored to your needs.

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Zhiyang Zhao, Ph.D.

Chief Scientific Officer

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Zhiyang Zhao, Ph.D., serves as Chief Scientific Officer (CSO) at Resolian. Dr. Zhao has over 30 years of pharmaceutical industry experience with special focus on drug metabolism and bioanalysis of small and large molecules in drug discovery and development. Dr. Zhao has previously held positions at Pfizer, GlaxoSmithKline, and Amgen. Before joining Resolian in 2015, Dr. Zhao served as Site Director of Preclinical Research at Amgen in Cambridge, Massachusetts, for over a decade. 

Currently, Dr. Zhao serves as an Adjunct Professor at the Eshelman School of Pharmacy of the University of North Carolina at Chapel Hill, North Carolina, and as Editor-in-Chief of Drug Metabolism & Bioanalysis Letters, a journal by Bentham Science, which publishes in all areas of drug metabolism and bioanalysis. Dr. Zhao received his Ph.D. degree in Medicinal Chemistry from Virginia Polytechnic and State University (popularly known as Virginia Tech) in Blacksburg, Virginia. 

 

Patrick Bennett

Chief Executive Officer

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Patrick Bennett has over 35 years of experience in pharmaceutical analysis and laboratory management. Now Chief Business Officer at Resolian, Patrick’s experience includes the roles of Strategic Marketing Director for Pharma with Thermo Fisher Scientific, LabCorp, and Vice President of Strategy and Development with PPD. 

Patrick earned a B.S. degree in Toxicology and a M.S. degree in Pharmacology from the College of Pharmacy and Allied Health at St. John’s University and an M.B.A in International Marketing from the Martin J. Whitman School of Management at Syracuse University.