List of equipment
and methods

AZ Biopharm is a GLP/GMP-certified test facility

List of equipment and methods

Physical and chemical testing:

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

Dissolution:

  • In-vitro dissolution USP-I + USP-II + USP-III; (offline) HPLC und UV-monitoring (Erweka)

GC systems:

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

HPTLC/TLC:

  • HPTLC/TLC qualitativ with photo documentation (UV, VIS, fluorescence)
  • HPTLC quantitativ with densitometer

HPLC systems:

  • HPLC-DAD
  • HPLC-Fluoreszenz
  • HPLC-MS/MS (inklusive PAL CTC Autosampler)
  • HPLC-RI
  • HPLC-UV/VIS
  • UHPLC-MS/MS
  • UPLC-DAD
  • UPLC-UV

Mass spectrometry:

  • GC-MS (EI/CI)
  • Headspace-GC-MS
  • SPME-GC-MS
  • HPLC-MSMS
  • UPLC-MSMS

Spectrophotometry:

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

Stability studies:

  • Climatic chambers and climate cabinets (all ICH conditions; special conditions from -80°C up to +55°C)
  • Photo stability: Atlas suntester/ WUT stability cabinet (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)