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Core Competences and Special Expertise

Our Core Competences and Special Expertise in Chemical-Physical and Pharmaceutical Analysis:

  • Amino acid analysis (e.g. determination of ninhydrin-positive substances)
  • Analysis of antibiotics
  • Analysis of substances without chromophore (e.g. using LC-ELSD, LC-CAD, LC-RI)
  • Assistance with downstream processing by analyzing for small molecules (e.g. methotrexate, aminoglycoside antibiotics, polysorbates, simethicone, polo­xamers, Triton X-100) in pharmaceuticals produced with biotechnology
  • Trace analysis of beta-propionic acid lactone in vaccines
  • Elemental analysis (AAS, ICP-OES, ICP-MS)
  • Extractables and Leachables studies
  • ICH Q3D elemental impurities testing
  • Genotoxic impurities
  • Determination of residual solvents
  • Release testing (USP I, II, IV)
  • Identification of impurities (LC-MS, GC-MS)
  • Capillary electrophoresis (e.g. capillary zone electrophoresis, CZE, micellar electrokinetic capillary chromatography, MEKC)
  • MS coupling (e.g. GC-MS, LC-MS, including LC-MS-Q-TOF)
  • Protein analysis (e.g. erythropoietin, EPO, insulin, antibodies, peptide mapping, determination of C-termina and N-termina, aggregate determination, glycan analysis)
  • Quality control of primary packaging materials (glass, plastic), including package leak testing
  • Analysis of highly potent substances (e.g. cytostatic agents) and photo-labile compounds

GBA PHARMA GMBH