Materials Characterization Testing Services

 

Technique

What Property Does It Measure?

What Is The Information Used For?

Physicochemical Properties

Inverse Gas Chromatography (iGC)

Surface energy

• Determination of surface interactions within formulations
• Studying effects of processing techniques e.g. blending, milling
• Assessing manufacturability, processability, aging, dissolution kinetics
• Studying drug-carrier interactions
• Optimization of formulation design

Dynamic Vapor Sorption (DVS)

Solvent interaction, hygroscopicity

• Formulation and packaging design
• Determining manufacture conditions
• Determining storage and transportation conditions
• Studying stoichiometry

Fourier Transform Infrared (FT-IR) Spectroscopy

 Chemical structure and identity

• Material identity confirmation
• Molecular structure and functional group determination
• Drug-excipient interaction determination
• Identification of impurities or contamination

Others

Viscosity, pH, Karl Fisher

Flowability, homogeneity, stability, solubility, dissolution rate, moisture content

Size & Shape

Light Microscopy

Particle size, shape and morphology

• Choosing optimal parameters for other techniques, e.g. laser diffraction
• Identifying particle behavior (e.g. agglomeration), and defects (e.g. contamination)
• Determining birefringence, crystallinity

Scanning Electron Microscopy (SEM)

Particle size, shape, morphology, behavior and interactions

• Nano- and micro-scale size and shape assessment
• Visualization of agglomeration and defects
• Identification of interactions between drug substance and excipients
• Choosing optimal parameters for other techniques, e.g. laser diffraction
• Studying the distribution of elements within drug particles (when combined with Energy Dispersive X-ray (EDX) spectroscopy)
• Identification of defects e.g. contamination

Laser Diffraction

Particle size distribution (PSD)

• Studying the effects of processing e.g. milling
• Developing new materials and products with desired PSD for optimal bioavailability, dissolution, absorption
• Optimizing manufacturing process

Dynamic Image Analysis (QICPIC)

Particle size and shape

• Better description of size and shape of non-spherical particles
• Identification of unusual particles, e.g. contamination, fibers
• Ensuring quality and batch consistency

Light Obscuration (HIAC)

Particle size

• Performing visible and sub-visible particulate matter testing

Surface

Gas Adsorption Analysis

Specific surface area and porosity

• Understanding dissolution rate, processing, useful shelf-life and bioavailability
• Stability of the API / excipient
• Selection of appropriate formulation and processing methods
• Optimization of drug release rate and targeting

Density

Gas pycnometry

True density and volume

• Ensuring quality and consistency of materials
• Supporting other characterization such as gas adsorption and modelling

Bulk & Tap Density

Density, packing properties

• Determine flowability, compressibility, compactability
• Determine packing and filling properties of materials

Solid Form Characterization

Powder X-ray Diffraction (PXRD)

Crystallinity, crystal structure, polymorphism, amorphous content, purity, phase identity

• Phase identification and purity
• Quantitative phase analysis
• Polymorphism screening and identification of optimal crystalline form
• Determination of crystallinity and amorphous content
• Determination of batch consistency
• Identification of contaminants
• Amorphous characterization

Differential Scanning Calorimetry (DSC)

Solvates, Hydrates, Glass Transition, Melting Point, Thermal Stability

• Determining compatibility and interactions between formulation components
• Assessing purity
• Amorphous content determination
• Glass transition point determination
• Support polymorph screening

Thermogravimetric Analysis (TGA)

Thermal stability, volatiles content (e.g. moisture, solvent), purity

• Determining hydration / solvation levels
• Determining degradation pathways
• Developing and optimizing manufacturing processes
• Designing packaging and storage conditions

Hot Stage Microscopy

Melting/boiling point, thermal stability, desolvation, phase transitions, miscibility

• Supporting formulation development
• Visualizing crystallization process, desolvation, polymorphism, phase transitions, melting/boiling points, glass transitions
• Troubleshooting problems
• Supplementing DSC and TGA data
• Supporting thermal analysis method development
• Cocrystal screening

Fourier Transform Infrared (FT-IR) Spectroscopy

Chemical structure and identity

• Material identity confirmation
• Molecular structure and functional group determination
• Drug-excipient interaction determination
• Identification of impurities and contamination

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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 CEO 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.