Research and development of active pharmaceutical ingredients and intermediates
Our research process is thorough and happens in two laboratories – organic synthesis and analytical laboratory, and is conducted by tasks, equipment, analysis objects and methods.
Organic synthesis laboratory
Task-based research
Development of chemical processes for obtaining new APIs
Conducting pre-exploratory laboratory research
Scaling up chemical processes from 10 mL to 6 L
Determination of process calorimetric parameters
Transfer of API laboratory synthesis to production
Synthesis of API impurity standard substances
Inspection of regulatory starting materials from new suppliers
Determination of critical quality attributes
Defining critical process parameters
Separation and identification of impurities
Investigation and evaluation of impurity carry over
Assessment of the presence of mutagenic, genotoxic and nitrosamine impurities
Equipment-based research
Chemical process development workstation (reaction calorimeter)
Probe to view particle size and shape in real time
Scaling up chemical processes from 10 mL to 6 L
Different types of thermostats for synthesis in reactors
Jacketed reactors from 0.5 to 6 L
Pressure filter
High pressure reactor 1 L
Mixers for high viscosity materials
Crystallisation workstation
Preparative flash chromatograph
Laboratory filtration centrifuge
Parallel reaction station
Lyophilizer
Analytical laboratory
Task-based research
Method development, validation, verification, transfer
Research by analysis objects
API, FDF, chemical products, intermediates, reference standards
Method-based research
Identification
Assay
Residual solvents
Related substances, genotoxic impurities and nitrosamines (from ppb level)
Determination of API residues on equipment surfaces and in the air
Dissolution of FDF
Particle size distribution (from 0.01 µm to a few mm)