Synthesis Development Services

• 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.