Take the next step with us.
The LPH lab was newly constructed in 2011. This lab provides our highly qualified employees with modern and comprehensive equipment, enabling them to use various analysis processes.
In our lab, we carry out professional, chemical-physical analyses of packaging materials, raw materials, intermediate goods and finished goods, based on pharmacopoeia stipulations or customer-specific test instructions (e.g. Ph. Eur., USP).
To check the stability of our products and raw materials, we store samples under the desired warehousing conditions (e.g. ICH conditions and special conditions) and take on the entire sample management and the analysis of stability samples at the agreed or prescribed testing times.
Our quality control offers optional validations and verifications, from the plan to the completion report.
- High-pressure liquid chromatography (UV, electrochemical detector, DAD)
- Gas chromatography (FID)
- Qualitative and quantitative HPTLC with UV scanner analysis
- UV/VIS spectroscopy
- NIR and ATR-IR spectroscopy
- Particle analyzer (microscope or Malvern)
- Automatic titration (incl. water analysis in accordance to European Pharmacopoeia)
- Planning of stability studies
- Creation of stability plans (test sheets)
- Performance of stability studies (ongoing, follow-up)
- Performance of in-use stability
- Stress tests (stability indicating)
- Storage of samples as part of stability tests
- Creation of final report
Climate conditions of stability checks:
- 2 °C – 8 °C
- 25 °C, 60 % rel. humidity
- 30 °C, 65 % rel. humidity
- 40 °C, 75 % rel. humidity
- Special conditions upon request
Validations and verifications
- Validation of inspection methods according to ICH guidelines
- Optimization of existing methods
- Verification of validated methods (e.g. Ph. Eur.)
- Method transfer