Patheon is a global provider of development and commercial manufacturing services for solid and sterile prescription drugs, offering a wide variety of services and products. SEE AND Read More »

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Physicochemical Properties Analysis

Patheon offers the full breadth of advanced sciences to characterize the physicochemical properties of your drug substance to generate the data required to build a CMC package for your IND filing and lead the way to clinical trials. By maximizing the efficiency and flexibility of a non-GMP environment, and with all the equipment in close proximity, we are able to quickly analyze and explore even small amounts of material and keep your project moving forward.

Characterization includes solubility – as a function of pH, temperature, solvents, stability – at IHC conditions for API, solutions and formulations, and identification of formulation options for in-vitro and preclinical in-vivo studies.

By having physicochemical characterization seamlessly integrated into a complete early development program that is driven by an experienced dedicated team, Patheon is the most rapid and cost-effective way to go from molecule to market.

Drug Substance analysis

  • FTIR and appearance
  • Polarized and hot stage microscopy
  • TGA/DSC, pXRD and DMS

Preformulation assessment

  • Aqueous and solvent solubility
  • KF, pKa and logD
  • Solution and solid state stability

Analytical method development

  • Non-GMP
  • Stability indicating
  • Assay and degradants
  • Related substances

Ask The Experts

Ann Newman, Ph.D.

Ann Newman, Ph.D.
Dr. Newman’s expertise is in solid-state chemistry: physical forms, polymorphism, salts, cocrystals,
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Robert A. Lipper, Ph.D.

Robert A. Lipper, Ph.D.
Having ushered multiple products to market though the entire development process, Dr. Lipper is an e
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K. George Mooney, Ph.D.

K. George Mooney, Ph.D.
Dr. Mooney has 35 years’ experience in pharmaceutical sciences and exploratory drug development. He
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Lynn Van Campen, Ph.D.

Lynn Van Campen, Ph.D.
With more than 30 years of drug development experience, Dr. Van Campen is an expert in the establish
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Mark A. Staples, Ph.D.

Mark A. Staples, Ph.D.
Having worked 32 years with all early to mid-stage companies, Dr. Staples is an expert at the early
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Rodney Pearlman, PhD.

Rodney Pearlman, PhD.
An expert in the development of scientific and business strategies for start-ups, Dr. Pearlman bring
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Roman Hlodan, Ph.D.

Roman Hlodan, Ph.D.
Dr. Hlodan is an expert in the development of biopharmaceuticals, including analytical method devel
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