Pharmaceutical analysis
We provide pharmaceutical analyses and homogeneity/stability studies on preclinical dosage forms to be administered according to GLP regulations.
Our special fields of expertise
- Development of analytical methods.
- Complete validation of analytical methods to support GLP analyses.
- Homogeneity-stability studies on preclinical forms.
Techniques and Equipment
The laboratory has state-of-the-art techniques and equipment including:
- HPLC: coupled with a detection UV/Vis, DAD, fluorescence, electrochemical detection.
- ICP-MS (agilent 7700 series).
- GC-MS (agilent 7890 A).
- AB Sciex: 7 LC-MS/MS (3*API 2000, 2*API 3000 and 2*API 4000).
- GC coupled with detection ECD and FID (Varian).
Scope
- On site studies and delegated phases for external GLP studies (multisite).
- Preclinical and in vitro (including Herg assay) studies.
- Verification of concentration prior to the start of the treatment phase and during the study (results are obtained prior to the use on that day).
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