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.
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:
- HPLC/UPLC: Detection methods: UV/VIS, Refractive Index, Fluorescence, and CAD
- GC and GC-Headspace: Detection methods: FID
- IC: Ion Chromatography
- Ultraviolet-visible spectrophotometry
- Fourier-transformation infrared spectrophotometry (FTIR)
- SDS Page
- Capillary Electrophoresis (CE and CE-SDS)
- Isoelectric focusing
- Micro Flow Imaging (MFI) System
- Compendial test methods
- Moisture determination: loss on drying, Karl-Fischer, titration
- Refractometry / Refractive Index
- Polarimetry / Optical Rotation
- Melting point
- pH measurement
- Titrimetric analysis: Manual & automated
- Other standard compendial tests (USP, Ph. Eur., BP, Ph. J.)
- Particulate matter testing (Hiac Royco, Microscope)
- Oxygen content
- Bioburden testing
- Endotoxin testing
- Sterility testing
Qualification and implementation of other analytical instruments is possible with individual arrangements.
Vetter offers storage and testing of stability samples according to ICH conditions.
- 25°C / 60%rh
- 30°C / 65%rh
- 40°C / 75%rh approx. 25-m² storage room
Additional temperatures are possible upon customer demand.