Analytical chemistry

Besides CMO services we offer a wide range of analytical services for pharma, biotech, chemical, agrochemical and food industry. 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. Our QC (Quality Control) lab is GMP and ISO-9001 certified and audited by both authorities and customers.

ANALYTICAL LABORATORY SERVICES:

  • Analytical method development, tech transfer and validation
  • Identification of by- and degradation products
  • Isolation of impurities by prep HPLC followed by identification
  • Degradation studies, stress testing
  • Qualification of reference standards

ROUTINE TESTING FOR PHARMA and OTHER INDUSTRIES:

  • Identification and characterization (NMR, CHN, IR, MS, etc)
  • Related substances and assay (HPLC, GC, titration, UV-VIS, etc)
  • Residual solvents (GC, GC-Headspace, Loss on drying (incl. in vacuum))
  • Karl Fischer (coulonometric, volumetric)
  • Testing according to Pharmacopoeia or in-house method
  • Various applications by HPLC, GC, UV-VIS, titrimetric, gravimetric, etc.
  • Testing according to client`s procedure, standard procedure or method developed in-house