Materials Characterization Services

Including Preformulation Studies

PPD provides a full range of physical and chemical characterization technologies to best support our clients' drug development programs. Our services support active pharmaceutical ingredient (API) analytical profiling, drug product preformulation and formulation development programs.

Variety of Materials Characterization Services

Our experts conduct distinct tests or help clients design a comprehensive program that will proactively address full characterization of a variety of materials. In addition, these services can be combined with other analytical techniques to help clients solve problems observed in the later phases of the drug development process.

Materials characterization services include:

• Chemical synthesis
• PKa
• Octanol/buffer partition and distribution coefficient determination
• Salt form screening and selection
• Polymorph screening
• Melting point, enthalpy, polymorph and phase transition determination (DSC, VT/RH XRPD)
• Hygroscopicity
• Crystal structure elucidation including microscopic characterization
• Process optimization and manufacturing support controls
• Particle-size analysis (dynamic laser scattering, optical, etc.)
• Zeta potential
• Method development
• Material and excipient compatibility studies
• Residual solvents
• Elemental analysis
• Solution and solid stressed thermal stability studies
• Solution and solid photostability evaluations
• Degradation profiling
• Impurity analysis and identification including intrinsic, co-solvent, intravenous, micellar and pH-solubility profiles
• Intrinsic dissolution
• Trace metal analysis (ICP/MS)
• Others (density, viscosity, refractive index, total organic carbon, FTIR, NIR, etc.)