Wed, 05/30/2018 - 16:35

Raw Materials for the Pharmaceutical Industry

The manufacture of pharmaceuticals in accordance with GMP guidelines places particular demands on the quality of raw materials. We test pharmaceutical raw materials, water and end products according to the harmonized methods of the European Pharmacopoeia (Ph. Eur.) as well as the United States Pharmacopeia (USP). These include:

  • Chapter 2.6.12 and 2.6.13: Microbiological examination of non-sterile products
  • Chapter 2.6.14: Bacterial endotoxins
  • Chapter 5.1.3: Efficacy of antimicrobial preservation
  • Monograph: Water for manufacturing extracts
  • Monograph 0008: Water, purified water
  • Monograph 0169: Water for injections
  • Additional tests upon request

Contact

Dr. Andreas Hartmann
Manager Division Bioanalytics
envelopeahartmann@nsf.org