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The laboratory at LPH was newly constructed in 2011. There, our highly qualified employees have modern and an extensive range of equipment at their disposal in order to apply the various required analytical methods.
In our laboratory, we carry out professional, chemical-physical analyses of packaging materials, raw materials, intermediate goods and finished goods according to pharmacopoeial specifications or customer-specific test instructions (e.g. as per the European Pharmacopoeia (Ph. Eur.) and United States Pharmacopoeia (USP)).
In order to test the stability of our products and starting materials, we store samples under the desired storage conditions (e.g. ICH conditions and special conditions) and take over complete sample management and analysis of the stability samples at the agreed or prescribed test times.
Our quality control department offers optional validations and verifications, from plan to final report.
- High performance liquid chromatography / HPLC (UV, electrochemical detector, DAD)
- Gas chromatography (FID)
- Qualitative and quantitative HPTLC with UV scanner evaluation
- UV/VIS spectroscopy
- NIR and ATR-IR spectroscopy
- Particle analyser (microscope or Malvern)
- Automatic titration (incl. water analysis as per Karl Fischer or KF titration)
- Planning stability studies
- Creating stability plans (test sheets)
- Conducting stability studies (ongoing, follow-up)
- Conducting in-use stability studies
- Conducting stress tests (stability indicating)
- Storing samples during the stability tests
- Creating final reports
Climatic conditions during stability tests:
- 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
- Validating test methods aas per the ICH guidelines
- Optimising existing methods
- Verifying validated methods (e.g. Ph. Eur.)
- Method transfers