Analytical R&D

Our analytical R&D (AR&D) teams support the process development groups with the following activities:

• Reference standard qualification
• Development and validation of analytical methods
• Final product testing
• Stability studies according to ICH guidelines

All development centers do have state-of the-art instrumental analysis equipment available and in use. For HPLC analytical methods, there is a number of different detectors available (UV, DAD, RI, ELSD) in order to support the product specific requirements.

For physical parameter testing, Sympatec and Malvern Laser equipment for the determination of the particle size distribution is available.