Raw materials

Physical and physico-chemical methods (Ph.Eur. & USP)

  • Clarity and degree of opalescence of liquids
  • Identification testing
  • Degree of coloration of liquids, including low volume method
  • Potentiometric determination of pH, including low volume method
  • Relative density
  • Refractive index
  • Optical rotation
  • Viscosity (capillary & rotating)
  • Distillation range
    • Boiling-, Melting-, Drop-, Freezing point
    • Residues testing (Sulphated-, Total ash)
    • Titration (amperometric, potentiometric & complexometric)
    • Atomic absorption/emission spectrometry
  • Light-spectrometry (IR & UV)
  • Chromatography (paper, thin layer, gas, liquid & size exclusion, UPLC)
    • Electrophoresis (NU-PAGE, SDS-PAGE, CE)
    • Loss on drying and water determination (coulometry, Karl Fisher)
  • Osmolality
  • Conductivity
  • Density of solids
  • Total organic carbon
  • Limit tests
  • Assays (acid-, ester-, hydroxyl-, iodine-, peroxide-, saponification values)
  • Assays (titrations, HPLC, UPLC)
  • Impurities (residual solvents, Ethylene oxide & dioxan, HPLC, UPLC-MS)

Microbiological methods (Ph.Eur. & USP)

  • Bioburden, TAMC, TYMC
  • Absence of specific micro-organisms
  • Preservative efficacy testing
  • Microbiological assay of antibiotics
  • Endotoxine testing (gel clot, kinetic methods)
  • Sterility testing
  • Particle counting