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Development/R&D of API’s and 
intermediates

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)

Equipment-based research

HPLC-UV, HPLC-MS/MS, GC-FID, GC-MS, GC-HS-FID, TLC
Titration (aqueous, non-aqueous, Karl Fischer, argentometry, precipitation)
UV, IR, Optical rotation
Laser light diffraction
Chemistry know-how

Outstanding chemistry know-how to
bring excellence in manufacturing

The chemistry knowledge and expertise that makes us specialists in medical research and development.

Quinuclidine derivatives

Adamantane derivatives

Chiral amino acids

Metalorganic chemistry

Aromatic and heterocyclic compounds

Handling of hazardous chemicals

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reachable together

Olpha is open to pharmaceutical contract manufacturing and co-development

Contract manufacturing

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