analytics

In the development of medicinal products, analytics is a vital core element to measure the results of the individual steps of formulation development. We can offer our clients all elements of development analytics:

  • Development and validation of testing procedures
  • Stress testing, stability testing
  • Release testing (manufacturing authorisation according to the Medicinal Products Act §13 for the approval of medicinal products)
  • Update of specifications and test methods and regulatory implementation (variation management)

For analytical work at our Appenweier site (HWI development), at our parent company HWI and at certified external service companies (Ext), we have access to the following processes and technologies:

  • Differential scanning calorimetry (DSC): HWI development GmbH
  • Laser light scattering (LLS): HWI development GmbH
  • Chromatography (HPLC, UPLC, LC-MS, GC, GC-MS): HWI development GmbH, HWI pharma services GmbH
  • In-vitro dissolution, EP and USP: HWI development GmbH
  • Infrared spectroscopy (FT-IR): HWI development GmbH, HWI ANALYTIK GmbH
  • RAMAN spectroscopy (RAMAN CI): Ext
  • X-ray microtomography (XMT): Ext
  • New Generation Impactor (NGI, Testing powder inhalers in accordance with EP and USP): HWI pharma services GmbH


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

 

 

 

DSC measuring chamber
 

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