Unlocking the secrets of API stability: a physicochemist's view

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Are you struggling with challenges related to the solubility, stability and manufacturability of your active pharmaceutical ingredients (APIs)?

The Developability Classification System (DCS) provides useful guidelines for selecting an appropriate approach to aid with bioavailability and solubility challenges. However, the guidelines don’t help you address issues related to the stability and manufacturability of pharmaceutical formulations. Overcoming these challenges requires extensive solid-form screening and new formulation types to create competitive pharmaceutical products. Solid form characterization, such as X-ray diffraction, scattering methods and thermal analysis techniques are orthogonal methods that can help you understand the structural and phase behavior of your APIs and excipients. Armed with these techniques you can unlock valuable insights into the properties and stability of a material and their shelf-life profile.

In this webinar we will investigate how the combination of X-ray diffraction, scattering techniques and thermal analysis methods enable thorough characterization.

How these techniques can be used to explain and predict the behavior of an API.

How XRPD, DSC and TGA can aid formulation developers with material selection.

How these techniques can help with understanding the impact of formulation processing operations on product performance.

Speakers

  • Dr. Natalia Dadivanyan - Application and Business Development, X-ray Products

More information

- Who should attend?

  • Anyone involved in stability studies
  • Anyone engaged in chemical development or support of scale up activities
  • Anyone engaged in polymorph screening activities as part of lead optimization activities
  • Anyone who is developing pharmaceutical formulations

- What will you learn?

  • Expand your knowledge of API characterization
  • Learn about stability assessment
  • Get insight on shelf-life behavior
  • Refresh your knowledge of X-ray diffraction and scattering techniques
  • Refresh your knowledge of thermal analysis methods