Extractables and Leachables

Expertise in E&L to support you from early stages of development through the full lifecycle of your product.

Resolian’s dedicated Extractables and Leachables (E&L) team will provide the data to allow assessment of the safety and compatibility of your product with its selected storage and delivery devices, as required by regulators. This analytical data will enable you to profile extractables from the primary packaging or device materials, and target leachables in the final product.

Resolian is committed to providing you the analytical solutions you need to ensure the safety and compliance of your products.

Reach out to us directly to learn more about Resolian’s Extractables & Leachables services.

Services in Detail

Resolian offers extensive expertise in assessing extractables and leachables testing, including:

  • Pharmaceuticals
  • Biopharmaceuticals
  • Animal healthcare
  • Consumer healthcare
  • Medical devices
  • Single-use systems
  • Nicotine delivery products

Tailored Study Designs: Tailored to your unique needs, and in line with the latest regulatory guidelines, Resolian delivers data to support a regulatory submission or change of manufacturing process, device component or supplier.

E&L Screening Studies: Extractables and Leachables studies utilize organic and inorganic screening methods (HS-GCMS, GCMS, HR-LCMS, ICP-MS) with a range of sample preparation techniques for your specific sample matrix to enable identification and quantification of compounds of concern.

Accelerated Leachables Studies: Can be utilized to provide you with timely results and insights into potential leachables and aid in defining the testing requirements for related stability trials.

Characterization of Unknowns: Resolian specializes in characterizing unknown components, providing you with a complete understanding of potential extractables and leachables.

Validation of Leachable Assay Methods: The E&L team can develop and validate assay methods for leachables of concern, allowing targeted monitoring throughout stability trials or shelf life of the product.

Extractable and leachable (E&L) testing provides vital information  concerning the potential for  impurities deriving from container closure systems, drug delivery devices and manufacturing  processes.

This contamination can present a  risk in terms of both patient safety and product efficacy.

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Zhiyang Zhao, Ph.D.

Chief Scientific Officer

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

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.