List of equipment
and methods

AZ Biopharm is a GLP/GMP-certified test facility

List of equipment and methods

Physical and chemical testing:

  • Boiling point
  • Conductivity
  • Densitometry
  • Disintegration
  • Breaking strength
  • Gravimetric tests
  • Ash
  • Drying loss
  • Sulphated ash
  • Halogen drying
  • Karl-Fischer Titration Ph. Eur. 2.5.12 and 2.5.32
  • Melting point
  • Osmolality
  • Oxygen measurement
  • Penetrometer
  • pH meter
  • Refraction index
  • Suppository Penetration Tester
  • Breaking strength, diameter, height, mass of dosage forms
  • Titration (e.g. potentiometric)
  • Viscosimeter
  • Visible particles (Ph.Eur. 2.9.20)
  • Wet chemistry (Ph. Eur, BP, USP; JP)
  • Polarimetry
  • Particle counts according to Pharm. Eur. 2.9.19

Dissolution:

  • Release USP-I + USP-II + USP-III; (offline) HPLC and UV monitoring

GC systems:

  • GC-MS
  • GC-EI
  • GC-CI
  • Headspace-GC-MS
  • SPME-GC-MS

HPTLC/TLC:

  • Qualitative HPTLC/TLC with photo documentation (UV, VIS, fluorescence)
  • Quantitative HPTLC with densitometer

HPLC systems:

  • HPLC-DAD
  • HPLC-fluorescence
  • HPLC-MS/MS (including PAL CTC Autosampler)
  • HPLC-RI
  • HPLC-UV/VIS
  • UPLC-DAD
  • UPLC-UV

Mass spectrometry:

  • GC-MS (EI/CI)
  • Headspace-GC-MS
  • SPME-GC-MS

Spectrophotometry:

  • FT-IR (ATR and crystal window)
  • UV/VIS Spectrophotometer

Stability studies:

  • Climatic chambers and climate cabinets (all ICH conditions; special conditions of -80°C up to +55°C)
  • Photostability: Atlas Suntester/WUT Stability chamber (ICH Q1B)

Safety weighing enclosures for work with cytostatic and highly active components (SafeTech)

Biological methods:

  • ELISA (Non GMP) (Equipment available)
  • Capillary electrophoresis (Equipment available)