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Analytical services

Starting materials

Vetter offers qualification, analysis, and release of the starting materials necessary for compounding of your drug product.

In-process samples, release, and stability testing

During early clinical development, Vetter offers a wide range of analytical services designed to allow quick-release analytical testing of your clinical material. This includes chemical, biochemical, and microbiological testing for in-process samples, release, and stability testing.

Method transfer

Vetter works with you to validate compendial chemical and microbiological methods and to transfer your validated product-specific microbiological and chemical analytical methods in-house, providing a seamless transfer to clinical manufacturing and allowing you to formally release your batches. We can streamline the transfer implementation of analytical methods such as:

  • Chromatography:
    • HPLC/UPLC: Detection methods: UV/VIS, Refractive Index, Fluorescence, and CAD
    • GC and GC-Headspace: Detection methods: FID
    • IC: Ion Chromatography
  • Spectroscopy:
    • Ultraviolet-visible spectrophotometry
    • Fourier-transformation infrared spectrophotometry (FTIR)
  • Elektrophoresis:
    • SDS Page
    • Capillary Electrophoresis (CE and CE-SDS)
    • ELISA
    • Isoelectric focusing
    • Micro Flow Imaging (MFI) System
    • Compendial test methods
  • Moisture determination: loss on drying, Karl-Fischer, titration
  • Refractometry / Refractive Index
  • Density 
  • Polarimetry / Optical Rotation
  • Melting point
  • pH measurement
  • Osmolarity
  • Titrimetric analysis: Manual & automated
  • Other standard compendial tests (USP, Ph. Eur., BP, Ph. J.)
  • Viscosity
  • Particulate matter testing (Hiac Royco, Microscope)
  • TOC
  • Conductivity
  • Oxygen content
  • Bioburden testing
  • Endotoxin testing
  • Sterility testing

Qualification and implementation of other analytical instruments is possible with individual arrangements.

Stability storage

Vetter offers storage and testing of stability samples according to ICH conditions.

  • 2°C-8°C
  • 25°C / 60%rh
  • 30°C / 65%rh
  • 40°C / 75%rh approx. 25-m² storage room

Additional temperatures are possible upon customer demand.

Webinar

Don't miss our upcoming webinar:

Don’t let your diluent be the weakest link in your drug product

October 13 | 10am EDT

Register now!