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As of the FDA and the German authorities inspected and accepted GMP-Lab, we develop analytical methods, validate according to the current ICH-guidelines and are proficient in chemical and microbiological analytics for the determination of pharmaceutical products, active substances and excipients in the terms of the § 14 (4) AMG and in compliance with the GMP- guidelines.

Hereunto belong

  • atomic absorption spectroscopy for element analysis
  • analysis of refractive index
  • density determination
  • capillary electrophoresis
  • dissolution testing with paddel-, bascet- und cylinder method and following determination of assay with HPLC, GC, UV etc.
  • thin layer chromatography
  • GC (FID, WLD, NPD)  and GC-MS determination of assay and purity testing
  • hardness testing of tablets with thickness, length  and  mass testing
  • HPLC/UPLC (DAD, VWD, RID, FLD) and HPLC-MS-MS determination of assay and purity testing
  • hygiene monitoring, with bacterial count of air and contact plates for surfaces
  • ion chromatographic assay
  • IR-spectroscopy
  • microbiological testing for efficacy of antimicrobial preservation of non sterile pharmaceutical preparations  
  • testing of the microbiological qualitiy of non sterile pharmaceutical preparations 
  • microscopy 
  • determination of residual solvents with GC
  • cleaning validation,  analytics of rinse- and swab samples
  • melting point testing
  • heavy metal analytics
  • heavy metals with ICP-MS, ICP-OES and AAS
  • stability testing including storage of stability samples, handling in GMP-motored climate chambers
  • titrations
  • TOC-analysis of purified water
  • UPLC assay and purity testing
  • UV-absorption testing
  • viscosity testing
  • water content with Karl-Fischer titration

and many other methods.