Analytics

Besides CMO services we offer a wide range of analytical services.

We are able to perform all required analyses in a fast and efficient manner, as well as full validation of analytical methods according to the ICH guidelines. The QC testing lab is GMP-certified and audited by authorities and customers.

We are currently applying also for ISO17025 certificate which will be available in the end of 2017.

We provide analytical services for the following industries:

  • PHARMA;
  • BIOTECH;
  • CHEMICAL AND AGROCHEMICAL;
  • FOOD AND BEVERAGES.

ANALYTICAL LABORATORY SERVICES INCLUDE:

  • ANALYTICAL METHOD:
    • development
    • tech transfer
    • validation
  • IDENTIFICATION OF BY- AND DEGRADATION PRODUCTS
  • ISOLATION OF IMPURITIES BY prep HPLC
  • DEGRADATION STUDIES, STRESS TESTING
  • QUALIFICATION OF REFERENCE STANDARDS

ROUTINE TESTING FOR PHARMA:

  • Identification and characterization (NMR, CHN, IR, MS, etc)
  • Related substances and assay (HPLC, GC, titration, UV-VIS, etc)
  • Residual solvents (GC, Loss on drying (incl. in vacuum))
  • Karl Fischer (coulonometric, volumetric)
  • Testing according to pharmacopoeia or in-house method

ROUTINE TESTING FOR OTHER INDUSTRIES:

  • Various applications by HPLC, GC, UV-VIS, titrimetric, gravimetric, etc.
  • Testing according to client`s procedure, standard procedure or method developed in-house