Polymorphism Screening

The importance of understanding and controlling the crystalline form produced cannot be overstated. The production of the incorrect polymorphic form can have an effect on a variety of parameters which will have an impact on the quality of your API.

Charles River has the ability to perform multiple crystallization screens to investigate solid-state polymorphism. Using a variety of techniques, we aim to identify and characterize all relevant polymorphic forms as well as any hydrates or solvates of your API. Ultimately, our goal is to identify and recommend the most thermodynamically stable form under ambient conditions and provide you with information on how to obtain it.

Polymorphism Characterization

  • XRPD to obtain a fingerprint diffractogram
  • TGA and DSC to understand thermal behavior
  • Microscopy to assess crystal habit (optical or SEM as appropriate)
  • Hot-stage microscopy to correlate with events observed in TGA and DSC
  • GVS to assess hygroscopicity
  • UPLC™ and 1H NMR to assess chemical purity, structural integrity and residual solvent levels
  • Storage under ICH guidelines to assess stability
  • Thermodynamic solubility and kinetic dissolution rates in any relevant media
  • Single-crystal X-ray diffraction (on special request)

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