The analytical development group at GEA Pharmaceutical A/S has a strong knowledge base in all aspects of analytical chemistry related to drug development. This includes development and validation of all relevant methods, setting of specifications as well as stability studies.

We feature state-of-art laboratories and develop analytical methods for active substances as well as for finished dosage forms, for release testing and stability studies.

The major instruments and techniques are:
  • HPLC with UV, PDA, RI and fluorescence detection
  • Ion chromatography with PDA and conductivity detection
  • UPLC with PDA detection
  • GC-FID with liquid or head-space injection
  • Automated titration equipment
  • Karl Fischer titration
  • Spectrometry (UV, IR)
  • Dissolution of finished dosage forms and API's
  • Disintegration
Analytical method validation is performed and documented according to GMP following the principles laid out by ICH. Documented method transfer ensures that the transferred method can be run with a high degree of confidence in the receiving laboratory.

GEA Pharmaceutical A/S has facilities for performing stability studies. We offer complete stability packages including experimental design, protocol, testing and report according to current standards and guidelines.
ANALYTICAL DEVELOPMENT
Analytical Development