drug substances

The quality of active pharmaceutical ingredients is characterised by a series of chemical and physical properties, which have a decisive influence on the stability and effect of a medicinal product. For a successful medicinal product development, it is absolutely essential to understand and, if possible, to optimise the chemical and physical quality of the active ingredient.
To do this, our investigations include the following parameters:

  • Chemical decomposition products, photosensitivity
  • Particle sizes, particle shapes
  • Polymorphism, crystallinity
  • Compatibility of APIs and excipients
  • Solubilities

If a certain quality of an active pharmaceutical ingredient needs to be sought and applied, we can offer our customers the following services:

  • API syntheses
  • API sourcing in accordance with current regulatory requirements (e.g. generic API in accordance with EP and USP)
  • API-IP search


Contact: Dr. Alexandra Keilbach-Bermann
Head of Drug Development and Production / Head of Quality
Email: a.keilbach-bermann(at)hwi-group.de
Phone: +49 7805 401-502

Very finely powdered API
 

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