Chemical R&D

Syntheses development projects we have solved so far were always finished by the patent application. For the period of our company’s existence, we have become authors of several patents of the original syntheses of generic APIs (sertralin, clopidogrel, valsartan). We contributed as co-developers in the four other patents of intermediates syntheses.

Besides the development of original RoS we offer:

  • Up-scaling and validation of the processes
  • Preparation of standards of impurities
  • Evaluation of patents
  • Studies on crystal polymorphism of pharmaceutical substances
  • All results reported according to documentation system based on EMEA and ICH regulatory guidelines

Examples of techniques employed:

  • Syntheses using carbonic acid derivatives: phosgenation and reaction of phosgene analogs, preparation and reaction of isocyanates, carbodiimides, orthoesters, chlorocarbonates, formamides, etc.
  • Preparation of heterocycles (triazoles, tetrazoles, chinoxalines, etc.)
  • Cyanoethylation and similar reactions of acrylates
  • Reduction with metals, hydrides, complex hydrides, reductive amination at normal pressure
  • Friedel -Crafts syntheses
  • Halogenation (aromatic, aliphatic, phenacylbromides, bromohydroxylation, halogen exchange etc.)
  • Amination, aminolysis
  • Syntheses using malonic esters, cyanoacetates, and other activated esters
  • Esterification and etherification of sensitive natural compounds, introduction and cleavage of various protecting groups
  • Preparation of special groups of compounds (catalyst for the Ziegler- Natta process, lights stabilizers and phenolic antioxidants)
  • Special laboratory procedures (high vacuum technique, inert and anhydrous techniques, preparative chromatography)
  • Modification and preparation of steroids
  • Asymmetric synthesis
  • Chiral separations

Analytical R&D

Our analytical laboratory is holder of GMP compliance of the manufacturer issued by the national authority of the Czech Republic – State Institute for Drug Control. We are holder of the Certificate on the Compliance with Principles of Good Laboratory Practice issued by the Ministry of Environment.

Main range of services we offer:

  • Analytical method development and validation
  • Routine analyses carried out by HPLC-MS-MS, HPLC-DAD, HPLC-RI, titration methods, polarimetry
  • Stress testing
  • Identification of degradation products resulting from stress and stability testing by HPLC-MS-TOF
  • Isolation and identification of impurities in drug substances and products
  • Development of chiral methods
  • Analyses of chiral analytes