Synthesis development
We have decades of experience in the development of chemical syntheses for active pharmaceutical ingredients which enables us to offer our customers a wide range of chemical process developments including the associated analytical development.
Our development offering includes:
- feasibility studies regarding the development of new chemical syntheses
- risk-based development of new, multi-stage chemical processes for the manufacture of active pharmaceutical ingredients in accordance with current guidelines (ICH Q9 and Q11)
- elaboration of alternative synthetic routes
- optimization of existing chemical syntheses (e.g. in terms of volume yields and throughput times, improvement of the economics of the process)
- scale-up of active ingredient syntheses
- investigations and establishment of purification processes using crystallization or chromatography
- development of crystallization processes to adjust particle size distributions
- characterization of end products and intermediates in API synthesis, including identification of impurities
- identification and qualification of impurities, including mutagenic and genotoxic substances, residual solvents and elemental impurities (ICH Q3A or Q3B, Q3C and Q3D and Q7)
- advice on all questions of API development
- literature research
Our wide-ranging analytics are a part of the development process from start to finish. In addition to standard chromatographic methods, our range of services also includes NMR spectroscopy, mass spectrometry and particle size analysis.
Contact Person: Dr Uwe Müller
